Clinical Global Impression (clinical + global_impression)

Distribution by Scientific Domains
Distribution within Medical Sciences

Terms modified by Clinical Global Impression

  • clinical global impression scale

  • Selected Abstracts

    A controlled trial of paroxetine for chronic PTSD, dissociation, and interpersonal problems in mostly minority adults,

    Randall 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 ,

    Moira 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]

    Amisulpride: a review of its efficacyin schizophrenia

    H. 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 practice

    R. 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]

    Comparison of carbamazepine and lithium in treatment of bipolar disorder: A systematic review of randomized controlled trials,

    Daniela 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]

    Galantamine: a randomized, double-blind, dose comparison in patients with Alzheimer's disease,

    D. 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 antipsychotics

    M. 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]

    Treatment of Premature Ejaculation in the Asia-Pacific Region: Results from a Phase III Double-blind, Parallel-group Study of Dapoxetine

    Chris 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]

    Association between painful physical symptoms and clinical outcomes in Taiwanese patients with major depressive disorder: A three-month observational study

    Kuang-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]

    Identification of bipolar disorder in women with postpartum depression

    BIPOLAR DISORDERS, Issue 3 2010
    Verinder 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 disorder

    BIPOLAR DISORDERS, Issue 5 2009
    Melissa 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 study

    BIPOLAR DISORDERS, Issue 8 2007
    Julia 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 review

    BIPOLAR DISORDERS, Issue 5 2004
    Claudia 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]

    A double-blind study of the efficacy of venlafaxine extended-release, paroxetine, and placebo in the treatment of panic disorder

    Mark 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]

    Olanzapine monotherapy for acute depression in patients with bipolar I or II disorder: results of an 8-week open label trial

    William 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]

    Effects of stimulus intensity on the efficacy and safety of twice-weekly, bilateral electroconvulsive therapy (ECT) combined with antipsychotics in acute mania: a randomised controlled trial

    BIPOLAR DISORDERS, Issue 2 2009
    Titus SP Mohan
    Objectives:, To examine differences in speed of improvement and remission in people with mania undergoing bilateral, brief-pulse, twice-weekly electroconvulsive therapy (ECT) at stimulus intensities administered just above and 2.5 times their individually titrated seizure threshold. Methods:, Consecutive, eligible subjects with mania, prescribed ECT, were randomised to receive treatments at stimulus doses either just above or 2.5 times their individually titrated seizure thresholds. Main outcomes were the speed of improvement and remission as measured by the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions,Improvement scale (CGI-I) and cognitive side effects assessed by the Mini-Mental State Exam, the Wechsler Memory Scale, and a scale for autobiographical memory. Results:, A total of 24/26 subjects (92.3%) given threshold ECT and 22/24 subjects (91.7%) given suprathreshold ECT were significantly improved [CGI = 2; odds ratio (OR) = 1.1, 95% confidence interval (CI): 0.1,8.4; p = 1.0] at the end of ECT. A total of 88% of the sample had remitted [YMRS < 10; threshold 23/26 (88.5%) versus suprathreshold 21/24 (87.5%)], with no significant differences between interventions (OR = 1.1, 95% CI: 0.2, 6.0; p = 1.0). The interventions did not differ significantly in the time or number of ECT treatments required for improvement or remission. Both interventions were equally safe. Conclusions:, Bilateral, twice-weekly ECT delivered at stimulus intensities just above individually titrated seizure threshold was as effective and safe as ECT administered at stimulus intensities 2.5 times seizure threshold in rapidly resolving the symptoms of acute mania. [source]

    Cocaine Rapid Efficacy Screening Trial (CREST): a paradigm for the controlled evaluation of candidate medications for cocaine dependence

    ADDICTION, Issue 2005
    Deborah B. Leiderman
    ABSTRACT Aim Development of effective medications for the treatment of cocaine dependence remains a major priority for the National Institute on Drug Abuse (NIDA) at the National Institutes of Health. The Cocaine Rapid Efficacy Screening Trial (CREST) paradigm was developed by the Division of Treatment Research and Development (DT R&D) at NIDA with the goal of enhancing pilot clinical trial validity when systematically assessing a range of medications and drug classes for potential utility in treatment of cocaine dependence. Design CREST utilizes a randomized, controlled, parallel group, blinded methodology for comparing one or more marketed medications against a standard, pharmaceutical grade placebo. The trial design is comprised of a flexible 2,4-week screening/baseline period followed by randomization to an 8-week treatment period. Measures Standard measures of outcomes for the CREST included urinary benzoylecgonine (primary metabolite of cocaine), retention, cocaine craving, depression, clinical global impression and HIV-risk behaviors. In order to facilitate comparisons of data from the CREST studies across sites, drug classes and time, standardized procedures, measures and psychosocial counseling were used. Results A total of 19 medications were evaluated in out-patient treatment research clinics in Boston, Cincinnati, Los Angeles, New York and Philadelphia. Conclusions Findings supported decisions to move forward three medications (cabergoline, reserpine, tiagabine) using full-scale, adequately powered, randomized placebo-controlled trial designs. Lessons learned from the CREST experience continue to shape cocaine pharmacotherapy trial design and execution. [source]

    Gender differences in clinical presentation and response to sertraline treatment of generalized anxiety disorder,

    Meir Steiner
    Abstract Objective To evaluate gender differences in the clinical presentation of generalized anxiety disorder (GAD) and response to sertraline treatment. Methods Adult outpatients who met DSM-IV criteria for GAD with a minimum Hamilton rating scale for anxiety (HAM-A) total score,,,18 were randomized to 12 weeks of double-blind treatment with flexible doses (50,150,mg) of sertraline (n,=,182; female, 59%) or placebo (n,=,188; female, 51%). Results Clinical presentation of GAD was very similar in men and women in terms of the severity of the HAM-A psychic factor, severity of concomitant depression symptoms, duration of GAD, quality of life and impairment in physical health. Women had an earlier age of onset and higher HAM-A somatic factor scores compared with men. For both men and women, treatment with sertraline resulted in greater change from baseline to endpoint on the HAM-A compared with placebo (adjusted change,±,SE: men: ,12.1,±,0.9 vs ,8.8,±,0.9; women: ,11.4,±,0.8 vs ,7.1,±,0.9, p,<,0.001); the interaction between gender and treatment group was not significant, nor was there a significant difference between the average change from baseline for men compared with women. Similarly, responder rates based upon clinical global impression,improvement (CGI-I) scores at endpoint showed no significant interaction between gender and treatment, nor was there a significant difference in the response rates by gender; however, the response rate of sertraline compared with placebo was significantly different (p,<,0.0001) (men: 64% vs 40%; women: 62% vs 34%). Similar findings were evident at week 4 assessment and for completers (week 12). Overall, sertraline was well tolerated by both men and women. Discussion Women and men with GAD showed similar clinical presentations, with the exception that women had an earlier age of onset and reported more somatic anxiety symptoms. Sertraline was an effective and well tolerated treatment for GAD in both men and women. Copyright © 2004 John Wiley & Sons, Ltd. [source]

    Milnacipran and pindolol: a randomized trial of reduction of antidepressant latency

    Michael T. Isaac
    Abstract Background New, better tolerated and faster treatments for depression are needed. Patients are understandably unhappy with having to wait 3 to 4 weeks for a response to an antidepressant, while experiencing side effects almost immediately. This frequently has an adverse effect on compliance and engagement with treatment. Aims The primary objective was to assess the activity of pindolol on the onset of antidepressive response of milnacipran. The secondary objective was to assess the number of responders among the patients who received milnacipran and pindolol versus patients who received milnacipran and placebo. The tertiary objective was to evaluate the safety of milnacipran and pindolol versus milnacipran and placebo. Method Randomized, double-blind, placebo-controlled study over 42 days. Setting Inner city London community mental health teams. Participants 80 patients were selected and gave written consent to treatment, 78 were randomized (39 in each group) and evaluated for safety (intention-to-treat, ITT, safety data set), 77 (ITT efficacy data set), and 64 (per protocol, PP, data set) were evaluated for efficacy. The mean age was 31.9 for the pindolol group and 32.3 for the placebo. Intervention All patients received milnacipran 50,mg twice a day plus either pindolol 2.5,mg (the ,pindolol group') or matching placebo (the ,placebo group') three times a day. Outcome measures The main efficacy variable was the Montgomery,Åsberg depression rating scale (MADRS) score at days 0, 4, 7, 10, 14, 21, 28, 42 on PP data set in an observation carried (OC) approach. Secondary efficacy variables were clinical global impression (global improvement) and Hamilton depression rating scale (HDRS). Results Improvement in MADRS total score was greater in the pindolol group than in the placebo group from day 7 (p=0.03). Responder rates in the clinical global impression were 97.2% for the pindolol group and 60.6% for the placebo group. The treatment was well tolerated with the most common side effects being nausea (28.2%; 35.9%), vomiting (7.7%; 23.1%), hot flushes (15.4%; 5.1%) and sweating (12.8%; 12.8%). Conclusion The milnacipran and pindolol combination is safe, well tolerated and efficacious in major depression, and represents a rational strategy for the possible acceleration or potentiation of antidepressant action. Copyright © 2003 John Wiley & Sons, Ltd. [source]

    Safety and efficacy of high dose of venlafaxine XL in treatment resistant major depression

    P. MbayaArticle first published online: 24 SEP 200
    Abstract Aim The aim of the study was to look at efficacy and the safety profile of high dose (450,600,mg) venlafaxine XL in five patients with treatment resistant major depressive illness. Methods Five patients with treatment resistant depression were treated with high dose venlafaxine XL. Efficacy was evaluated using the Montgomery,Asberg depression rating scale (MADRS), the 21-item Hamilton rating scale for depression (HAM-D-21) and the clinical global impressions (CGI) scale. Level of functioning was evaluated by social adaptation self-evaluation scale (SASS). Body weight, supine pulse and blood pressure were recorded. Results The response rate was based on a 50% decrease in MADRS and HAM-D scores between weeks 1 and 24. There was a more than 50% decrease in MADRS scores in 3 of 5 patients and 4 of 5 patients in HAM-D scores. There was a trend to improvement of SASS scores in three of the study patients and in two of them the mean scores were within the normal range. Supine pulse and blood pressure remained stable in four patients, except in one patient where there was a slight increase although the final reading at week 24 was normal. Weight was relatively stable in all three patients where it was recorded, but in one patient there was a slight increase which may have been due to an atypical neuroleptic the patient was taking at the time. Conclusion High dose venlafaxine was safe, well tolerated and effective in this small number of severe treatment resistant patients with major depression and it also improved social functioning. Copyright © 2002 John Wiley & Sons, Ltd. [source]

    Rotigotine improves restless legs syndrome: A 6-month randomized, double-blind, placebo-controlled trial in the United States,,§

    MOVEMENT DISORDERS, Issue 11 2010
    Wayne A. Hening MD
    Abstract This randomized, double-blinded, placebo-controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6-month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score , 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once-daily transdermal patch (fixed-dose regimen). The two co-primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI-1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were ,4.5 (95% CI: ,6.9, ,2.2) for 2 mg/24 hr rotigotine, ,5.2 (95% CI: ,7.5, ,2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 ,0.65 (95% CI: ,1.0, ,0.3) and ,0.9 (95% CI: ,1.3, ,0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6-month double-blind period. © 2010 Movement Disorder Society [source]