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Impression
Kinds of Impression Terms modified by Impression Selected AbstractsMAKING AN IMPRESSION: REPLICATION AND THE ONTOLOGY OF THE GRAECO-ROMAN SEAL STONEART HISTORY, Issue 2 2006VERITY PLATT The debate on replication in ancient art has traditionally concentrated upon Roman ,copies' of famous Greek sculptures and paintings. This article explores a different, but no less significant, kind of replication , the use of intaglio gems as seals to create wax impressions. The mechanical transmission of a glyptic image from one medium to another played an important role in Graeco-Roman society, conferring authority upon the seal as an individual or state signature employed in legal, political and personal exchange. The direct relationship between seal and impression was also appropriated by Greek philosophers as a metaphor for unmediated sense perception , the ,impressions' made by material objects upon the soul. However, as a comparison with the ontological issues surrounding the modern photograph shows, the seemingly unproblematic relationship between image and impression is more complex than may initially seem: the seal's philosophical appeal lay ultimately more in its social significance , as a guarantor of authenticity and marker of the self , than in its true ontological status. [source] Efficacy and safety of duloxetine in the treatment of generalized anxiety disorder: a flexible-dose, progressive-titration, placebo-controlled trialDEPRESSION AND ANXIETY, Issue 3 2008Moira Rynn M.D. Abstract Generalized anxiety disorder (GAD), a prevalent and chronic illness, is associated with dysregulation in both serotonergic and noradrenergic neurotransmission. Our study examined the efficacy, safety, and tolerability of duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and norepinephrine, for short-term treatment of adults with GAD. In a 10-week, double-blind, progressive-titration, flexible-dose trial, 327 adult outpatients with a DSM-IV,defined GAD diagnosis were randomized to duloxetine 60,120,mg (DLX, N=168) or placebo (PLA, N=159) treatment. The primary efficacy measure was mean change from baseline to endpoint in Hamilton Anxiety Scale (HAMA) total score. Secondary outcome measures included response rate (HAMA total score reduction ,50% from baseline), Clinician Global Impression,Improvement (CGI-I) scores, and Sheehan Disability Scale (SDS) scores. Patients who received duloxetine treatment demonstrated significantly greater improvement in HAMA total scores (P=.02); a higher response rate (P=.03), and greater improvement (P=.04) than patients who received placebo. Duloxetine-treated patients were also significantly more improved than placebo-treated patients on SDS global functional (P<.01) and work, social, and family/home impairment scores (P<.05). The rate of discontinuation due to adverse events (AEs) was higher for the duloxetine group compared with the placebo group (P=.002). The AEs most frequently associated with duloxetine were nausea, dizziness, and somnolence. Duloxetine was an efficacious, safe, and well-tolerated treatment that resulted in clinically significant improvements in symptom severity and functioning for patients with GAD. Depression and Anxiety 0:1,8, 2007. © 2007 Wiley-Liss, Inc. [source] A controlled trial of paroxetine for chronic PTSD, dissociation, and interpersonal problems in mostly minority adults,DEPRESSION AND ANXIETY, Issue 2 2007Randall D. Marshall M.D. Abstract This study evaluated the efficacy of paroxetine for symptoms and associated features of chronic posttraumatic stress disorder (PTSD), interpersonal problems, and dissociative symptoms in an urban population of mostly minority adults. Adult outpatients with a primary DSM-IV diagnosis of chronic PTSD received 1 week of single-blind placebo (N = 70). Those not rated as significantly improved were then randomly assigned to placebo (N = 27) or paroxetine (N = 25) for 10 weeks, with a flexible dosage design (maximum 60,mg by week 7). Significantly more patients treated with paroxetine were rated as responders (14/21, 66.7%) on the Clinical Global Impression,Improvement Scale (CGI-I) compared to patients treated with placebo (6/22, 27.3%). Mixed effects models showed greater reductions on the Clinician-Administered PTSD Scale (CAPS) total score (primary plus associated features of PTSD) in the paroxetine versus placebo groups. Paroxetine was also superior to placebo on reduction of dissociative symptoms [Dissociative Experiences Scale (DES) score] and reduction in self-reported interpersonal problems [Inventory of Interpersonal Problems (IIP) score]. In a 12-week maintenance phase, paroxetine response continued to improve, but placebo response did not. Paroxetine was well tolerated and superior to placebo in ameliorating the symptoms of chronic PTSD, associated features of PTSD, dissociative symptoms, and interpersonal problems in the first trial conducted primarily in minority adults. Depression and Anxiety 24:77,84, 2007. Published 2006 Wiley-Liss, Inc. [source] Early response and 8-week treatment outcome in GAD ,DEPRESSION AND ANXIETY, Issue 8 2006Moira Rynn M.D. Abstract Our objective was to compare the predictive value of early response to treatment outcome in patients with generalized anxiety disorder (GAD) treated with benzodiazepines, serotonin receptor (5HT-1A) partial agonists, or placebo. Data from two double-blind GAD studies were combined. Subjects were evaluated with the Hamilton Anxiety Scale (HAM-A) and the Clinical Global Impression of Improvement (CGI-I) scale over 8 weeks. Categories of response at weeks 1 and 2 were defined by the HAM-A total score. Analyses of covariance and Kaplan,Meier survival analyses were the primary analyses used to assess 8-week end point treatment outcomes as a function of early improvement. HAM-A change from baseline to weeks 1 and 2 significantly predicted last observation carried forward (LOCF) response at week 8 for both medications and for placebo (P<.001). Early improvement was a strong predictor for treatment outcome irrespective of whether active medication or placebo was the treatment agent. Depression and Anxiety 23:461,465, 2006. Published 2006 Wiley-Liss, Inc. [source] A randomized, placebo-controlled trial of paroxetine in nursing home residents with non-major depressionDEPRESSION AND ANXIETY, Issue 3 2002Adam B. Burrows M.D. Abstract Depression is common across a broad spectrum of severity among nursing home residents. Previous research has demonstrated the effectiveness of antidepressants in nursing home residents with major depression, but it is not known whether antidepressants are helpful in residents with less severe forms of depression. We conducted a randomized double-blind placebo-controlled 8-week trial comparing paroxetine and placebo in very old nursing home residents with non-major depression. The main outcome measure was the primary nurse's Clinical Impression of Change (CGI-C). Additional outcome measures were improvement on the interview-derived Hamilton Depression Rating Scale (HDRS) and Cornell Scale for Depression (CS) scores. Twenty-four subjects with a mean age of 87.9 were enrolled and twenty subjects completed the trial. Placebo response was high, and when all subjects were considered, there were no differences in improvement between the paroxetine and placebo groups. Two subjects that received paroxetine developed delirium, and subjects that received paroxetine were more likely to experience a decrease in Mini Mental State Exam scores (P = .03). There were no differences in serum anticholinergic activity between groups. In a subgroup analysis of 15 subjects with higher baseline HDRS and CS scores, there was a trend toward greater improvement in the paroxetine group in an outcome measure that combined the CGI-C and interview-based measures (P = .06). Paroxetine is not clearly superior to placebo in this small study of very old nursing home residents with non-major depression, and there is a risk of adverse cognitive effects. Because of the high placebo response and the trend towards improvement in the more severely ill patients, it is possible that a larger study would have demonstrated a significant therapeutic effect for paroxetine as compared with placebo. The study also illustrates the discordance between patient and caregiver ratings, and the difficulties in studying very elderly patients with mood disorders. Depression and Anxiety 15:102,110, 2002. © 2002 Wiley-Liss, Inc. [source] Amisulpride: a review of its efficacyin schizophreniaACTA PSYCHIATRICA SCANDINAVICA, Issue 400 2000H. J. Möller Objective: To assess the efficacy of the new atypical antipsychotic drug, amisulpride. Method: Studies comparing the efficacy of amisulpride with that of haloperidol and risperidone, respectively, are reviewed. Outcome measures were Clinical Global Impression, Brief Psychiatric Rating Scale (BPRS), and Positive And Negative Symptom Scale (PANSS) scores. Results: Amisulpride was at least as effective as haloperidol and risperidone in the improvement of positive symptoms, and significantly more efficacious than haloperidol in reducing PANSS negative subscores (P=0.038) in patients with acute exacerbations. Amisulpride demonstrated a greater improvement in BPRS total scores (P<0.05) and PANSS negative subscores (P=0.0001) than haloperidol after 12 months of treatment in chronic schizophrenic patients with acute exacerbations. Conclusion: Amisulpride can thus be considered for use as first-line treatment of acute and chronic schizophrenia. [source] A single question for the rapid screening of restless legs syndrome in the neurological clinical practiceEUROPEAN JOURNAL OF NEUROLOGY, Issue 9 2007R. Ferri The purposes of this study were to validate the use of a single standard question for the rapid screening of restless legs syndrome (RLS) and to analyze the eventual effects of the presence of RLS on self-assessed daytime sleepiness, global clinical severity and cognitive functioning. We evaluated a group of 521 consecutive patients who accessed our neurology clinic for different reasons. Beside the answer to the single question and age, sex, and clinical diagnosis, the following items were collected from all patients and normal controls: the four criteria for RLS, the Epworth Sleepiness Scale (ESS), the Clinical Global Impression of Severity (CGI-S), and the Mini-Mental State evaluation. RLS was found in 112 patients (70 idiopathic). The single question had 100% sensitivity and 96.8% specificity for the diagnosis of RLS. ESS and CGI-S were significantly higher in both RLS patient groups than in normal controls. RLS severity was significantly higher in idiopathic than in associated/symptomatic RLS patients. RLS can be screened with high sensitivity and good reliability in large patient groups by means of the single question; however, the final diagnosis should always be confirmed by the diagnostic features of RLS and accompanied by a careful search for comorbid conditions. [source] Topiramate Treatment of Chronic Migraine: A Randomized, Placebo-Controlled Trial of Quality of Life and Other Efficacy MeasuresHEADACHE, Issue 8 2009Stephen Silberstein MD Objective., To define yet more clearly the utility of topiramate in the treatment of chronic migraine, we evaluated prespecified secondary endpoints from a recent randomized, double-blind, placebo-controlled, multicenter clinical trial. Background., We previously reported that topiramate 100 mg per day produced a statistically significant reduction in mean monthly migraine/migrainous and migraine headache days compared with placebo treatment and that it was safe and generally well tolerated. Methods., Variables analyzed included between-treatment group differences in percent responders, change in the mean monthly rate of total headache days and headache-free days, change in average and worst daily headache severity, change in the mean monthly use of acute headache medications, and absolute change and percent change in a headache index. Additional analyses included evaluation of changes in: the associated symptoms of photophobia, phonophobia, and nausea; Migraine-Specific Quality of Life Questionnaire scores; Migraine Disability Assessment Scale scores; and Physician's and Subjects Global Impression of Change. Results., The intent-to-treat population consisted of 306 patients (topiramate, n = 153; placebo, n = 153). Categorical responder rates of reductions in mean monthly migraine/migrainous days for topiramate- vs placebo-treated subjects were as follows: for ,25% reduction: 68.6% vs 51.6% (P = .005); ,50%: 37.3% vs 28.8% (P = .093); and ,75%: 15.0% vs 9.2% (P = .061). The decrease in mean monthly total headache days and headache-free days for topiramate vs placebo treatment was 5.8 vs 4.7 days (P = .067). Compared with placebo, topiramate treatment resulted in statistically significant mean improvements in the Role Restrictive (P = .028) and Emotional Function (P = .036) domains of the Migraine-Specific Quality of Life Questionnaire, in the worst daily severity of migraine (P = .016), severity of photophobia (P = .032), frequency of vomiting (P = .018), photophobia (P = .038), phonophobia (P = .010), unilateral pain (P = .015), pulsatile pain (P = .023), and pain worsened because of physical activity (P = .047). In addition, there were trends observed (favoring topiramate) in average daily severity of migraine (P = .077), acute headache medication use (P = .127), severity of nausea (P = .098), frequency of nausea (P = .166), the Role Preventive domain of the Migraine-Specific Quality of Life Questionnaire (P = .061), and severity of phonophobia (P = .062). Conclusions., In addition to significantly reducing mean monthly migraine/migrainous and migraine headache days, treatment of chronic migraine with topiramate was effective with regard to several traditionally important and clinically relevant secondary outcomes in migraine prevention trials. Treatment with topiramate was well tolerated and not associated with serious adverse events. [source] Comparison of carbamazepine and lithium in treatment of bipolar disorder: A systematic review of randomized controlled trials,HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 1 2009Daniela Ceron-Litvoc Abstract Objectives To review data from randomized controlled trials (RCTs) assessing the comparative efficacy of carbamazepine and lithium in treatment of acute manic and maintenance phase of bipolar disorder (BD). Design RCTs were identified through a search strategy that included: electronic databases, reference cross-checking, hand search of non-indexed publications, and book chapters on the treatment of BD comparing carbamazepine with lithium. Outcomes investigated were antimanic effect, trial withdrawal, relapse, hospitalization, need for rescue medication, and presence of adverse effects. Selection of studies and data analysis were performed independently by authors. Whenever possible, data from trials were combined through meta-analyses. Relative risks (RR) were estimated for dichotomous data. Results In acute mania, carbamazepine was similar to lithium on the following outcomes: trial withdrawal due to adverse effects, number of participants with at least one adverse effect, improvement in the Clinical Global Impression (CGI). In acute mania, carbamazepine was associated with fewer trial withdrawals. In maintenance treatment, carbamazepine was similar to lithium in relapses and hospitalization, but there were fewer trial withdrawals due to adverse effects on lithium. Conclusion This review suggests that carbamazepine might be comparable to lithium in terms of efficacy and safety, and therefore a valuable option in the treatment of both manic and maintenance phases. Copyright © 2008 John Wiley & Sons, Ltd. [source] Olanzapine does not enhance cognition in non-agitated and non-psychotic patients with mild to moderate Alzheimer's dementiaINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 11 2005John Kennedy Abstract Objective This was an exploratory study of olanzapine as potential treatment for improvement in cognition in patients with Alzheimer's disease without prominent psychobehavioral symptoms. Methods Non-psychotic/non-agitated patients (n,=,268) with Alzheimer's disease, who had baseline Mini-Mental State Examination (MMSE) scores of 14,26 were randomized to treatment with olanzapine (2.5 to 7.5,mg/d) or placebo for 26 weeks. The primary objectives were to determine if treatment with olanzapine improved cognition as indexed by the Alzheimer's disease Assessment Scale for Cognition (ADAS-Cog) and the Clinician's Interview-Based Impression of Change (CIBIC) after 26 weeks of therapy. Results Patients treated with olanzapine vs placebo experienced significant worsening ADAS-Cog scores at weeks 12 (p,=,0.03) and 26 (p,=,0.004). Changes in CIBIC scores were not significantly different between treatment groups at either assessment. A post hoc analysis revealed that olanzapine-treated patients with more cognitive impairment at baseline (MMSE scores of 14,18) (n,=,35) experienced significantly greater deterioration in ADAS-Cog performance than patients in the placebo group (n,=,24; p,<,0.001); whereas in patients with less cognitive impairment (n,=,78, baseline MMSE scores of 23,26) between-group ADAS-Cog changes were not significant. Conclusions In this 26-week study non-psychotic/non-agitated patients with Alzheimer's disease treated with olanzapine experienced significant worsening of cognition as compared to placebo. Copyright © 2005 John Wiley & Sons, Ltd. [source] Galantamine: a randomized, double-blind, dose comparison in patients with Alzheimer's disease,INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 9 2001D. Wilkinson Abstract Objectives To investigate whether Galantamine significantly improves the core symptoms of Alzheimer's disease (AD). Background Galantamine is a reversible, competitive, selective inhibitor of acetylcholinesterase (AChE) that also allosterically modulates nicotinic acetylcholine receptors. This dual mechanism of action provided the rationale for a phase II trial of galantamine in AD. Method A multicentre, randomized, parallel, double-blind, placebo-controlled trial was carried out to evaluate the efficacy and tolerability of galantamine 18, 24 and 36,mg/day administered for 3 months in 285 patients with mild-to-moderate probable AD. The primary outcome measure was the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog); secondary outcome measures were the Clinical Global Impression of Change (CGIC) and the Progressive Deterioration Scale (PDS). Results Patients treated with galantamine 24,mg/day had a significantly better outcome than placebo on ADAS-cog; the treatment difference was 3 points on the intention-to-treat (ITT) analysis ( p,=,0.01) and 4.2 points on per protocol analysis ( p,=,0.001). Per protocol analysis showed that galantamine had a significantly better outcome than placebo on PDS ( 24-mg/day dose, p,<,0.05) and CGIC (36-mg/day dose, p,<,0.05). Galantamine was well tolerated at the lower doses of 18 and 24,mg/day where it produced mild, transient effects typical of cholinomimetic agents. Conclusion This study shows that, relative to placebo, galantamine significantly improves the core symptoms of Alzheimer's disease. Copyright © 2001 John Wiley & Sons, Ltd. [source] Alterations of liver function test in patients treated with antipsychoticsJOURNAL OF CLINICAL LABORATORY ANALYSIS, Issue 6 2003M. Teresa Garcia-Unzueta Abstract The prevalence of alterations of liver function tests in patients treated with a wide range of antypsychotics is unknown. The aim of this study was to analyze the effects of antipsychotics on liver function tests in a population of schizophrenic outpatients. Concentrations of AST, ALT, GGT, alkaline phosphatase, albumin, and bilirubin were determined in 54 patients fitting DSM-IV criteria of schizophrenia, and the same number of sex- and age-matched healthy subjects. Assessments included the Clinical Global Impression (CGI) and the Positive and Negative Syndrome Scale (PANSS) in addition to treatment related variables. Transaminases concentrations were slightly elevated in study patients compared to healthy controls, but without statistical significance. Alkaline phosphatase showed higher values in schizophrenic patients. Albumin and bilirubin were lower in study patients. Liver function tests abnormalities were found in about 10% of schizophrenic patients treated with antipsychotics. Treatment with depot phenotiazines induces alteration in these tests more frequently than treatment with other antipsychotics. PANSS negative subscale scores directly correlated with alkaline phosphatase and inversely correlated with albumin. A substantial number of patients in treatment with antipsychotic drugs present alterations of liver function tests. Both pharmacological and clinical factors could be related with these alterations. J. Clin. Lab. Anal. 17:216,218, 2003. © 2003 Wiley-Liss, Inc. [source] Factors influencing long-term changes in mental health after interferon-alpha treatment of chronic hepatitis CALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2009F. SCHMIDT Summary Background, Antiviral treatment with interferon-alpha (IFN-,) is associated with several acute psychiatric side effects. Little is known about long-term effects on mental health after treatment independent from viral response and the influence of pre-existing psychiatric risk-factors. Aim, To evaluate long-term effects of antiviral treatment with interferon-alpha (IFN-,) on mental health in patients with psychiatric risk factors. Method, We prospectively investigated long-term mental health changes in 81 hepatitis C virus-infected patients. Psychiatric outcome was measured with the Montgomery,Asberg Depression Scale (MADRS), Brief Psychiatric Rating Scale, the Global Social Functioning Scale and the Global Clinical Impression Scale 6 months after the end of antiviral treatment with IFN-, and ribavirin. Results, Six months after antiviral therapy, 49% of the patients showed a worsening and 27.2% an improvement of depression scores. The most important predictor for a long-term improvement of depression scores was a pre-treatment MADRS score ,5 (OR 14.21, 95% CI: 2.51,81.30). Patients with pre-existing psychiatric disorders (OR = 0.117, 95% CI: 0.024,0.558), methadone substitution (OR = 0.20, 95% CI: 0.045,0.887) or genotype 2/3 (OR = 0.341, 95% CI: 0.138,0.845) were significantly less likely to show a long-term worsening of depressive symptoms. Conclusions, Pre-existing psychiatric risk factors increase the chance for a long-term improvement and reduce the risk for a long-term worsening of mental health after antiviral treatment of chronic hepatitis C with IFN-,. [source] Psychometric attributes of the SCOPA-COG Brazilian versionMOVEMENT DISORDERS, Issue 1 2008Francisco Javier Carod-Artal MD Abstract Cross-cultural adaptation and independent psychometric assessment of the Scales for Outcomes in Parkinson's disease-Cognition (SCOPA-COG), Brazilian version was performed. Parkinson's disease (PD) patients were evaluated by means of the SCOPA-Motor scale, Hoehn and Yahr staging (HY), Clinical Impression of Severity Index-PD (CISI-PD), Parkinson Psychosis Rating Scale, and Hospital Anxiety and Depression Scale. Cognition was evaluated using the Mini-Mental State Examination (MMSE), Short Portable Mental Status Questionnaire (SPMSQ), and SCOPA-COG. The following attributes were explored: acceptability, scaling assumptions, reliability, precision, and construct validity. One hundred fifty-two patients were assessed (mean age, 63.2 years; disease duration, 7.8 years; median HY stage, 3). Mean SCOPA-COG and MMSE were 18.2 and 25.7, respectively. The internal consistency of the SCOPA-COG (Cronbach's alpha = 0.81; item-total correlation, 0.38,0.62) was satisfactory. While the intraclass correlation coefficient value was 0.80, weighted kappa ranged from 0.30 (dice task) to 0.72 (animal fluency task). The standard error of measurement value for the SCOPA-COG was 3.2, whereas the smallest real difference was 8.9. SCOPA-COG total scores significantly decreased as the HY stage increased (Kruskal-Wallis, P < 0.0001). Age, years of education, and PD duration (all, P < 0.001) were observed to have an independent, significant effect on the SCOPA-COG. The SCOPA-COG is a short, reliable, valid instrument that is sensitive to cognitive deficits specific to PD. © 2007 Movement Disorder Society [source] Comparison between reduction in 24-hour pad weight, International Consultation on Incontinence-Short Form (ICIQ-SF) score, International Prostate Symptom Score (IPSS), and Post-Operative Patient Global Impression of Improvement (PGI-I) score in patient evaluation after male perineal slingNEUROUROLOGY AND URODYNAMICS, Issue 1 2007Christian O. Twiss Abstract Aims We assessed the utility of three self-assessment instruments: the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the post-operative Patient Global Impression of Improvement (PGI-I) score, and the International Prostate Symptom Score (IPSS) by correlating them with an objective outcome, the change in 24-hr pad weight, after a male perineal sling. Methods Twenty-six men with urodynamically confirmed stress incontinence underwent a male perineal sling. Patients were evaluated pre-operatively and post-operatively with a 24-hr pad test, IPSS and ICIQ-SF. Patients also completed the PGI-I post-operatively. Changes in study parameters were compared via the paired t -test, and correlations were performed using Spearman's rho. Results There were significant reductions in 24-hr pad weight (,274 g, P,<,0.001), percentage 24-hr pad weight (54.2%), ICIQ-SF score (,6.3, P,<,0.001), and the three ICIQ-SF subscores (,1.2, ,1.7, ,3.4 for Questions 3, 4, and 5, respectively, P,<,0.001 for all). The change in total ICIQ-SF score and the post-operative PGI-I score correlated strongly with percentage reduction in 24-hr pad weight (r,=,,0.68, P,<,0.001; r,=,,0.81, P,<,0.001, respectively) and with each other (r,=,0.79, P,<,0.001). The change in all three ICIQ-SF subscores correlated significantly with percentage reduction in 24-hr pad weight and with post-operative PGI-I score. There was no significant change in the IPSS or the voiding or storage subscores, and none correlated with any other study parameter. Conclusions This study validates the construct validity of the ICIQ-SF and PGI-I in the assessment of treatment for male stress incontinence and should make clinicians confident in comparing studies of incontinence treatment utilizing the change ICIQ-SF score, the post-operative PGI-I score, and percentage reduction in 24-hr pad weight as outcome measures. Neurourol. Urodynam. © 2006 Wiley-Liss, Inc. [source] Treatment of Premature Ejaculation in the Asia-Pacific Region: Results from a Phase III Double-blind, Parallel-group Study of DapoxetineTHE JOURNAL OF SEXUAL MEDICINE, Issue 1pt1 2010Chris McMahon MBBS, FAChSHM ABSTRACT Introduction., Dapoxetine is a short-acting selective serotonin reuptake inhibitor that was recently approved for the on-demand treatment of premature ejaculation (PE). Aim., To evaluate the efficacy and safety of dapoxetine 30 mg and 60 mg on demand (prn) in men with PE from the Asia-Pacific region. Methods., This randomized, double-blind, parallel-group, placebo-controlled trial enrolled men who were 18 years or older; in a monogamous, heterosexual relationship for at least 6 months; met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, criteria for PE for at least 6 months; and had an intravaginal ejaculatory latency time (IELT) of 2 minutes or less in at least 75% of sexual intercourse episodes. Subjects received placebo, dapoxetine 30 mg, or dapoxetine 60 mg prn (1,3 hours before intercourse) for 12 weeks. Main Outcome Measures., Stopwatch-measured Average IELT, the Premature Ejaculation Profile (PEP), Clinical Global Impression (CGI) of change in PE, treatment-emergent adverse events (TEAEs). Results., Of the 1,067 subjects randomized, 858 completed the study. Mean Average IELT increased from approximately 1.1 minutes at baseline (across groups) to 2.4, 3.9, and 4.2 minutes with placebo, dapoxetine 30 mg, and dapoxetine 60 mg, respectively, and geometric mean Average IELT increased from approximately 0.9 minutes at baseline (across groups) to 1.8, 2.7, and 3.1 minutes, respectively (fold-increases of 2.0, 2.8, and 3.3, respectively). All PEP measures and the CGI of change were significantly improved with dapoxetine vs. placebo at study endpoint (P , 0.005 for all). The most common TEAEs with dapoxetine included nausea, dizziness, somnolence, headache, vomiting, diarrhea, and nasopharyngitis; TEAEs led to discontinuation in 0.3%, 1.7%, and 5.1% of subjects with placebo, dapoxetine 30 mg, and dapoxetine 60 mg, respectively. Conclusions., Dapoxetine treatment significantly prolonged IELT and improved PEP measures and was generally well tolerated in men with PE in the Asia-Pacific region. McMahon C, Kim SW, Park NC, Chang C, Rivas D, Tesfaye F, Rothman M, and Aquilina J on behalf of the dapoxetine 3003 study investigators. Treatment of premature ejaculation in the Asia-Pacific region: Results from a phase III double-blind, parallel-group study of dapoxetine. J Sex Med 2010;7:256,268. [source] Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: Results of a randomized, double-blind, placebo-controlled trial,ARTHRITIS & RHEUMATISM, Issue 9 2010Lesley M. Arnold Objective To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia. Methods A double-blind, placebo-controlled trial was performed to assess 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients underwent 4,6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment. Two composite responder definitions were used as primary end points to classify the response to treatment. The 2-measure composite response required achievement of ,30% improvement from baseline in the pain score and a rating of "very much improved" or "much improved" on the Patient's Global Impression of Change (PGIC) scale. The 3-measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 (SF-36) physical component summary (PCS) score. Results After 12 weeks of stable-dose treatment, a significantly greater proportion of milnacipran-treated patients compared with placebo-treated patients showed clinically meaningful improvements, as evidenced by the proportion of patients meeting the 2-measure composite responder criteria (P < 0.001 in the baseline observation carried forward [BOCF] analysis) and 3-measure composite responder criteria (P < 0.001 in the BOCF). Milnacipran-treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes, including 24-hour and weekly recall pain score, PGIC score, SF-36 PCS and mental component summary scores, average pain severity score on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire total score (all P < 0.001 versus placebo), and Multidimensional Fatigue Inventory total score (P = 0.036 versus placebo). Milnacipran was well tolerated by most patients, with nausea being the most commonly reported adverse event (placebo-adjusted rate of 15.8%). Conclusion Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia. [source] Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: A randomized, double-blind, placebo-controlled, multicenter clinical trial,ARTHRITIS & RHEUMATISM, Issue 1 2009I. Jon Russell Objective To evaluate the safety and efficacy of sodium oxybate for management of the symptoms of fibromyalgia syndrome (FMS). Methods Patients with FMS (according to the American College of Rheumatology 1990 criteria) were randomized, after discontinuing their prestudy medications for FMS, to receive 4.5 gm or 6 gm of sodium oxybate or matching placebo once per night for 8 weeks. The primary outcome variable (POV) was a composite score for changes from baseline in 3 coprimary self-report measures: patient's pain rating (in daily electronic diaries) on a visual analog scale (PVAS), the Fibromyalgia Impact Questionnaire (FIQ) score, and the Patient Global Impression of Change (PGI-C). A beneficial response rate for the POV composite score was defined as ,20% improvement in the PVAS and FIQ scores plus a rating of "much better" or "very much better" on the PGI-C. Secondary measures included subjective sleep outcomes (on the Jenkins Scale for Sleep) and quality-of-life measures. The analyses were based on an intent-to-treat (ITT) population. Results The ITT population included 188 patients with FMS, 78% of whom completed the trial. Significant benefit was observed with both dosages of sodium oxybate, according to changes in the POV and subjective sleep quality. Improvements in the PVAS score were significantly correlated with sleep outcomes. Sodium oxybate was well tolerated overall; dose-related nausea (,28% of patients) and dizziness (,18% of patients) tended to resolve with continued therapy. Conclusion Sodium oxybate therapy was well tolerated and significantly improved the symptoms of FMS. Further study of sodium oxybate as a novel therapeutic option for FMS is warranted. [source] Association between painful physical symptoms and clinical outcomes in Taiwanese patients with major depressive disorder: A three-month observational studyASIA-PACIFIC PSYCHIATRY, Issue 3 2010Kuang-Peng Chen MD Abstract Introduction: Reports from non-Asian populations indicate that painful physical symptoms are associated with poorer clinical and functional outcomes in patients with Major Depressive Disorder (MDD). This paper shows the changes in disease characteristics and quality of life in Taiwanese MDD patients, with or without painful physical symptoms, over 3 months' observation. Methods: Taiwanese patients from an observational study of six East Asian countries/regions were classified as painful physical symptom positive (PPS+) or negative (PPS,) based on a mean score of ,2 or <2, respectively, on the modified Somatic Symptom Inventory. Changes from baseline in outcomes were compared between the groups. Results: Of 194 patients with MDD, 69% were PPS+ at baseline. These PPS+ patients were more depressed (17-item Hamilton Depression Rating Scale total; mean [SD] 27.1 [6.26] versus 21.8 [5.94] PPS,, P<0.001), in more pain (Visual Analog Scale overall; median [range] 73.5 [9,100] versus 40 [0 to 80] PPS,, P<0.001) and had poorer quality of life at baseline (EuroQoL; mean [SD] 42.9 [18.26] versus 59.8 [18.21] PPS,,P<0.001). At endpoint (n=118), PPS, patients showed greater improvement on depression outcomes (Clinical Global Impression of Severity; P=0.011) and had a higher remission rate (52.8 % versus 14.6% PPS+, P=0.007). Discussion: Painful physical symptoms were frequently observed in Taiwanese patients with MDD. As PPS are associated with more severe depression, poorer quality of life, and poorer remission outcomes, clinical management should address both the mental and physical symptoms associated with this disorder. [source] The assessment of frailty in older people in acute careAUSTRALASIAN JOURNAL ON AGEING, Issue 4 2009Sarah N Hilmer Aim:, Develop a measure of frailty for older acute inpatients to be performed by non-geriatricians. Method:, The Reported Edmonton Frail Scale (REFS) was adapted from the Edmonton Frail Scale for use with Australian acute inpatients. With acute patients aged over 70 years admitted to an Australian teaching hospital, we validated REFS against the Geriatrician's Clinical Impression of Frailty (GCIF), measures of cognition, comorbidity and function, and assessed inter-rater reliability. Results:, REFS was moderately correlated with GCIF (n = 105, R = 0.61, P < 0.01), Mini-Mental State Examination impairment (n = 61, R = 0.49, P < 0.001), Charlson Comorbidity Index (n = 59, R = 0.51, P < 0.001) and Katz Daily Living Scale (n = 59, R = 0.51, P < 0.001). Inter-rater reliability of REFS administered by two researchers without medical training was excellent (kappa = 0.84, n = 31). Conclusion:, In this cohort of older acute inpatients, REFS is a valid, reliable test of frailty, and may be a valuable research tool to assess the impact of frailty on prognosis and response to therapy. [source] Identification of bipolar disorder in women with postpartum depressionBIPOLAR DISORDERS, Issue 3 2010Verinder Sharma Sharma V, Khan M. Identification of bipolar disorder in women with postpartum depression. Bipolar Disord 2010: 12: 335,340. © 2010 The Authors. Journal compilation © 2010 John Wiley & Sons A/S. Objective:, No studies to date have assessed the pharmacological management of treatment-resistant postpartum depression. We reviewed the pharmacological treatment of postpartum depression in patients diagnosed with treatment-resistant ,unipolar' depression. Methods:, We conducted a chart review of patients treated consecutively at a perinatal clinic. Treatment-resistant postpartum depression was defined as a failure to respond to at least one adequate antidepressant trial. Patients were diagnosed using the DSM-IV criteria, and the Clinical Global Impression,Improvement (CGI-I) rating scale was used to assess response to various pharmacological interventions. Results:, The majority of patients (57%, 34/60) referred for postpartum depression actually suffered from bipolar disorder. All patients were on antidepressants at the time of referral, but by the end of the study 37% (22/60) continued on antidepressants alone or in combination with other medications. CGI-I ratings showed appreciable improvement in depression at the end of six months following the initial consultation. Very much improvement was noted in 65% (39/60) of patients, and 22% (13/60) were considered much improved. The most common change in medication was a switch to or addition of an atypical neuroleptic. Limitations:, Retrospective design, small sample size, and lack of a control group. Conclusions:, Management of treatment resistance in women with postpartum depression should be considered within the context of types of mood disorders. Atypical neuroleptics and mood stabilizers used alone or as adjuncts should be considered in the treatment of resistant postpartum depression in patients with a bipolar diathesis. [source] A double-blind, placebo-controlled pilot study of quetiapine for depressed adolescents with bipolar disorderBIPOLAR DISORDERS, Issue 5 2009Melissa P DelBello Objective:, To conduct a pilot study comparing the effects of quetiapine and placebo for the treatment of depressive episodes in adolescents with bipolar I disorder. Method:, Thirty-two adolescents (ages 12,18 years) with a depressive episode associated with bipolar I disorder were randomized to eight weeks of double-blind treatment with quetiapine, 300,600 mg/day, or placebo. This two-site study was conducted from March 2006 through August 2007. The primary efficacy measure was change in Children's Depression Rating Scale,Revised Version (CDRS-R) scores from baseline to endpoint. Secondary efficacy measures included change in CDRS-R scores over the eight-week study period (PROC MIXED), changes from baseline to endpoint in Hamilton Anxiety Rating Scale (HAM-A), Young Mania Rating Scale (YMRS), and Clinical Global Impression,Bipolar Version Severity (CGI-BP-S) scores, as well as response and remission rates. Safety and tolerability were assessed weekly. Results:, There was no statistically significant treatment group difference in change in CDRS-R scores from baseline to endpoint (p = 0.89, effect size =,0.05, 95% confidence interval: ,0.77,0.68), nor in the average rate of change over the eight weeks of the study (p = 0.95). Additionally, there were no statistically significant differences in response (placebo =67% versus quetiapine = 71%) or remission (placebo = 40% versus quetiapine = 35%) rates, or change in HAM-A, YMRS, or CGI-BP-S scores (all p > 0.7) between treatment groups. Dizziness was more commonly reported in the quetiapine (41%) than in the placebo (7%) group (Fisher's exact test, p = 0.04). Conclusions:, The results suggest that quetiapine monotherapy is no more effective than placebo for the treatment of depression in adolescents with bipolar disorder. However, limitations of the study, including the high placebo response rate, may have contributed to our findings and should be considered in the design of future investigations of pharmacological interventions for this population. [source] Rapid tryptophan depletion as a treatment for acute mania: a double-blind, pilot-controlled studyBIPOLAR DISORDERS, Issue 8 2007Julia Applebaum Objectives:, Rapid reduction of up to 80% in plasma tryptophan level can be accomplished by administering an oral tryptophan-free amino acid solution, which induces hepatic protein synthesis and thereby depletes available plasma tryptophan. Rapid tryptophan depletion (RTD) has been shown to induce transient depressive symptoms in patients with remitted major depression. The effect of RTD in acutely manic patients has not been studied. Methods:, We carried out a double-blind, placebo-controlled pilot study of RTD in acutely manic patients. Patients were randomized to the treatment groups. Sodium valproate treatment was started at a dose of 1000 mg/day and continued throughout the 7-day study. On days 1-7, patients received a daily tryptophan-free amino acid drink or a placebo drink. The tryptophan-free amino acid drink contained a mix of amino acids without tryptophan. The placebo drink contained the additives and constituents of the real mixture to provide identical flavor and texture without the amino acids. Ratings were administered at baseline and then repeated on days 3, 5, and 7. All ratings were carried out by an experienced rater who was blind to the group assignment of patients. Results:, A total of 23 patients entered the study and 17 completed the 7-day treatment protocol. The patients who received the amino acid drink showed greater improvement in mania ratings. The differences in Young Mania Rating Scale (YMRS) and Clinical Global Impression (GCI) scores were significant. However, the intolerance rate was high (23%) and the findings in this pilot study are based only on results from those patients who were able to tolerate the drink. Conclusions:, Rapid tryptophan depletion may have an antimanic effect. [source] Acute treatment of bipolar depression with adjunctive zonisamide: a retrospective chart reviewBIPOLAR DISORDERS, Issue 5 2004Claudia F Baldassano Background:, This retrospective chart review evaluated the use of zonisamide as adjunctive treatment in patients with bipolar depression. Method:, The charts of outpatients with bipolar I or II disorder treated with adjunctive zonisamide were reviewed. The efficacy of zonisamide was assessed via comparison of physician-rated Global Assessment of Functioning (GAF) and Clinical Global Impression of Severity (CGI-S) Scale scores at baseline and after 6 weeks of therapy using paired t -tests. Patients who scored ,2 on the CGI-S after 6 weeks of zonisamide therapy were considered good responders to zonisamide. Results:, Charts for 12 patients (four men and eight women) with a mean (±SD) age of 39.6 (±7.6) years were evaluated. Patients received a mean (±SD) zonisamide dosage of 236 (±68) mg/day. Mean GAF scores significantly improved from 44.0 at baseline to 59.3 at week 6 (P = 0.05). Mean CGI-S scores improved from 4.54 at baseline to 3.42 at week 6, but the change was not statistically significant. Six patients (50.0%) were considered responders to zonisamide. Four patients discontinued zonisamide therapy, two for an adverse event (sedation) and two for lack of efficacy. Conclusions:, Zonisamide may be a useful adjunctive treatment for some patients with bipolar depression. Conclusions from this study are limited due to its retrospective design. Further investigation of zonisamide in the treatment of bipolar depression is warranted. [source] Long-term rivastigmine treatment in a routine clinical settingACTA NEUROLOGICA SCANDINAVICA, Issue 3 2009L. Minthon Objective,,, The aim of the study was to observe the effects of long-term rivastigmine treatment in patients with mild to moderate Alzheimer's disease (AD) in a routine clinical setting. Methods,,, This was a prospective, open-label, observational, multicentre, non-randomized study. Outcome measures included the Mini Mental State Examination (MMSE), the Clinician's Interview-Based Impression of Change (CIBIC) and the Alzheimer's Disease Assessment Scale , cognitive subscale (ADAS-cog). Results,,, Of 217 patients initiated into rivastigmine treatment, 62% (n = 135) remained on treatment for 24 months. Most patients droped out due to nursing home placement or side effects. Eighty per cent and 67% of completers exhibited a symptomatic attenuation of cognitive decline (, 4-point deterioration) as assessed by using the MMSE and ADAS-cog respectively. Forty-four per cent showed an unchanged/improved CIBIC rating. Conclusions,,, Over 60% of patients remained on treatment for 2 years in this routine clinical setting. In patients who remained on treatment, rivastigmine appeared to stabilize their condition and prevented or delayed symptomatic decline. [source] A double-blind study of the efficacy of venlafaxine extended-release, paroxetine, and placebo in the treatment of panic disorderDEPRESSION AND ANXIETY, Issue 1 2007Mark H. Pollack M.D. Abstract To date, no large-scale, controlled trial comparing a serotonin,norepinephrine reuptake inhibitor and selective serotonin reuptake inhibitor with placebo for the treatment of panic disorder has been reported. This double-blind study compares the efficacy of venlafaxine extended-release (ER) and paroxetine with placebo. A total of 664 nondepressed adult outpatients who met DSM-IV criteria for panic disorder (with or without agoraphobia) were randomly assigned to 12 weeks of treatment with placebo or fixed-dose venlafaxine ER (75,mg/day or 150,mg/day), or paroxetine 40,mg/day. The primary measure was the percentage of patients free from full-symptom panic attacks, assessed with the Panic and Anticipatory Anxiety Scale (PAAS). Secondary measures included the Panic Disorder Severity Scale, Clinical Global Impressions,Severity (CGI-S) and ,Improvement (CGI-I) scales; response (CGI-I rating of very much improved or much improved), remission (CGI-S rating of not at all ill or borderline ill and no PAAS full-symptom panic attacks); and measures of depression, anxiety, phobic fear and avoidance, anticipatory anxiety, functioning, and quality of life. Intent-to-treat, last observation carried forward analysis showed that mean improvement on most measures was greater with venlafaxine ER or paroxetine than with placebo. No significant differences were observed between active treatment groups. Panic-free rates at end point with active treatment ranged from 54% to 61%, compared with 35% for placebo. Approximately 75% of patients given active treatment were responders, and nearly 45% achieved remission. The placebo response rate was slightly above 55%, with remission near 25%. Adverse events were mild or moderate and similar between active treatment groups. Venlafaxine ER and paroxetine were effective and well tolerated in the treatment of panic disorder. Depression and Anxiety 24:1,14, 2007. © 2006 Wiley-Liss, Inc. [source] McDowell, Sellars, and Sense ImpressionsEUROPEAN JOURNAL OF PHILOSOPHY, Issue 2 2006Willem A. DeVries First page of article [source] Olanzapine monotherapy for acute depression in patients with bipolar I or II disorder: results of an 8-week open label trialHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 1 2010William V. Bobo Abstract We evaluated the efficacy, tolerability, and safety of olanzapine monotherapy in 20 adult patients with bipolar I or II disorder, depressed phase. Patients received open-label olanzapine monotherapy (mean modal dose, 15,mg/day) for 8 weeks. Assessments of psychopathology (Montgomery,Asberg Depression Rating Scale [MADRS], Quick Inventory of Depressive Symptomatology [QIDS-SR-16], Young Mania Rating Scale [YMRS]), clinical global state (Clinical Global Impressions [CGI] scale), and safety/tolerability were performed at baseline, and at 1, 2, 4, 6, and 8 weeks. Seventeen patients (85.0%) completed the study. Improvement in MADRS total scores was observed after the first week of treatment, and at all remaining follow-up time points (p,,,0.005). Parallel improvement in QIDS-SR-16 (p,<,0.001) and CGI-Severity (p,<,0.001) was observed between baseline and study endpoint. Nine (45%) subjects achieved positive treatment response, eight of whom (40%) also achieved symptom remission. There were significant increases in weight (+3.2,kg, p,=,0.001) and body mass index (+1.1,kg/m2, p,=,0.001), but not fasting glucose or lipids, with the exception of reduced triglyceride levels in the overall sample, and reduced HDL cholesterol in females. Olanzapine may be an effective, well-tolerated option for treating acute non-psychotic depression across a variety of bipolar disorder subtypes. Copyright © 2009 John Wiley & Sons, Ltd. [source] Improving clinical descriptions to understand the effects of dementia treatment: consensus recommendationsINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 11 2002Kenneth Rockwood Abstract Objectives To recommend how the description of clinically detectable treatment effects might be improved for antidementia drug trials. Method Consensus conference, with review of available evidence. Results We suggest widespread, systematic, qualitative studies, based on prospective observations such as the clinicians' narrative descriptions of patient's changes used in the Clinician's Interview-Based Impressions of Change (CIBIC-Plus), plus caregiver input. The identification of patient and caregiver expectations, and an understanding of how these expectations are met, are proposed as priorities for future study. Conclusion Better descriptions of treatment effects can enhance our understanding of both clinical meaningfulness and cholinergic function in the brain. Copyright © 2002 John Wiley & Sons, Ltd. [source] Tissue alterations after tooth extraction with and without surgical trauma: a volumetric study in the beagle dogJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 4 2008Stefan Fickl Abstract Objectives: The aim of this study is to evaluate whether tooth extraction without the elevation of a muco-periosteal flap has advantageous effects on the resorption rate after tooth extraction. Material and Methods: In five beagle dogs polyether impressions were taken before the surgery. The roots of the first and second pre-molars (P1 and P2) were extracted and the sites were assigned to one of the following treatments: treatment group (Tx) 1, no treatment; Tx 2, surgical trauma (flap elevation and repositioning); Tx 3, the extraction socket was filled with BioOss Collagen® and closed with a free soft-tissue graft; Tx 4, after flap elevation and repositioning, the extraction socket was treated with BioOss Collagen® and a free soft-tissue graft. Impressions were taken 2 and 4 months after surgery. The casts were scanned, matched together with baseline casts and evaluated with digital image analysis. Results: The "flapless groups" demonstrated significant lower resorption rates both when using socket-preservation techniques and without. Furthermore, socket-preservation techniques yielded better results compared with not treating the socket. Conclusion: The results demonstrate that leaving the periosteum in place decreases the resorption rate of the extraction socket. Furthermore, the treatment of the extraction socket with BioOss Collagen® and a free gingival graft seems beneficial in limiting the resorption process after tooth extraction. [source] | ||||||||||||||||||||||||||||||||||||||||||||||||||||