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Week Trial (week + trial)
Selected AbstractsEarly adversity in chronic depression: clinical correlates and response to pharmacotherapy,,DEPRESSION AND ANXIETY, Issue 8 2009Daniel N. Klein Ph.D. Abstract Background: There is growing evidence suggesting that early adversity may be a marker for a distinct pathway to major depressive disorder (MDD). We examined associations between childhood adversity and a broad variety of clinical characteristics and response to pharmacotherapy in a large sample of patients with chronic forms of MDD. Methods: Subjects included 808 patients with chronic forms of MDD (chronic MDD, double depression, or recurrent MDD with incomplete recovery between episodes and a total continuous duration of >2 years) who were enrolled in a 12-week open-label trial of algorithm-guided pharmacotherapy. Baseline assessments included a semi-structured diagnostic interview, and clinician- and self-rated measures of depressive symptoms, social functioning, depressotypic cognitions, and personality traits, and childhood adversity. Patients were re-evaluated every 2 weeks. Results: A longer duration of illness; earlier onset; greater number of episodes, symptom severity, self-rated functional impairment, suicidality, and comorbid anxiety disorder; and higher levels of dysfunctional attitudes and self-criticism were each associated with multiple forms of childhood adversity. A history of maternal overcontrol, paternal abuse, paternal indifference, sexual abuse, and an index of clinically significant abuse each predicted a lower probability of remission. Among patients completing the 12-week trial, 32% with a history of clinically significant abuse, compared to 44% without such a history, achieved remission. Conclusions: These findings indicate that a history of childhood adversity is associated with an especially chronic form of MDD that is less responsive to antidepressant pharmacotherapy. Depression and Anxiety, 2009. Published 2009 Wiley-Liss, Inc. [source] Cardiac function and antiepileptic drug treatment in the elderly: A comparison between lamotrigine and sustained-release carbamazepineEPILEPSIA, Issue 8 2009Erik Saetre Summary Purpose:, To investigate the comparative effects of carbamazepine (CBZ) and lamotrigine (LTG) on electrocardiography (ECG) parameters in elderly patients with newly diagnosed epilepsy. Methods:,, The study was conducted in the Norwegian subcohort (n = 108) of an international randomized double-blind 40-week trial, which compared the efficacy and tolerability of LTG and sustained-release CBZ in patients aged 65 and older with newly diagnosed epilepsy. Target maintenance doses were 400 mg/day for CBZ and 100 mg/day for LTG, with adjustments based on clinical response. Patients with significant unpaced atrioventricular (AV) conduction defect were excluded. Resting 12-lead ECG recordings were made under standardized conditions at pretreatment (baseline) and at the 40-week study visit (treatment visit). Changes in QRS interval (primary endpoint), heart rate (HR), PQ, and QTc (HR-corrected QT) intervals were assessed and compared between groups. Results:, Of the 108 patients randomized, 33 discontinued prematurely because of adverse events (n = 24, none of which was cardiac) or other reasons (n = 9), and 15 were nonevaluable due to incomplete ECG data. None of the assessed ECG parameters differed significantly between groups at baseline. No significant ECG changes were recorded between baseline and treatment visit for QRS duration and QTc intervals, whereas HR fell and PQ intervals increased slightly on both treatments. However, there were no differences between groups in changes from baseline to treatment visit. There were no significant relationships between individual ECG changes and serum drug concentrations, except for QTc intervals, which decreased slightly with increasing CBZ concentrations. The proportion of patients with ECG parameters outside the normal range at treatment visit was similar to that recorded at baseline. Discussion:, Clinically significant ECG changes are not common during treatment with CBZ or LTG in elderly patients with no preexisting significant AV conduction defects. [source] Valproate-induced thrombocytopenia: a prospective monotherapy studyEPILEPSIA, Issue 3 2008Wassim Nasreddine Summary Purpose: The frequency of valproate (VPA)-induced thrombocytopenia varied widely in previous studies, due to methodological differences. Our objective was to evaluate the relationship between trough VPA plasma levels and platelet counts and assess risk factors for the development of thrombocytopenia. Methods: Patients with refractory partial epilepsy were enrolled in this double-blind, multicenter, concentration,response trial that evaluated the efficacy and safety of high versus low trough plasma VPA concentrations following administration of divalproex sodium as monotherapy. Trough VPA concentrations and concomitant platelet counts were drawn at baseline and intermittently throughout the 24-week trial. Bivariate correlations and multivariate stepwise regression analysis were performed between platelet counts and multiple variables. A logistic regression analysis was done to determine the probability of developing thrombocytopenia at various VPA levels. Results: A total of 851 VPA levels and concomitant platelet counts were analyzed in 265 patients. Of these, 17.7% of patients experienced at least one episode of thrombocytopenia (platelet count , 100,000/,l) after exposure to divalproex sodium. A significant negative correlation was found between VPA levels and platelet counts. Women were significantly more likely to develop thrombocytopenia. The probability of developing thrombocytopenia substantially increased at trough VPA levels above 100 ,g/ml in women and above 130 ,g/ml in men. Discussion: Our data strongly support a causal relationship between rising plasma VPA levels and reduced platelet counts, with additional risk factors including female gender and lower baseline platelet counts. [source] Baclofen for binge eating: An open-label trialINTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 8 2007Allegra I. Broft MD Abstract Objective: Baclofen is a GABA-B agonist that may be useful in the treatment of substance use disorders, and also reduces ,binge-like' eating in rodents. We hypothesized that baclofen might be effective in reducing binge eating episodes in binge eating disorder (BED) and bulimia nervosa (BN). Method: Seven women with BED (n = 4) or BN (n = 3) took baclofen (60 mg/day) for 10 weeks. Results: Six out of seven patients completed the full 10-week trial. Five out of seven participants (3 BED; 2 BN) demonstrated 50% or greater reduction of frequency of binge eating from beginning to end of the study. Three out of seven participants (2 BED; 1 BN) were free of binge eating at study end. Four out of seven participants elected to continue baclofen at study end. Baclofen was well tolerated by the participants. Conclusion: In this open-label trial, baclofen was associated with decreased binge eating frequency in patients with BED and BN. © 2007 by Wiley Periodicals, Inc. Int J Eat Disord 2007 [source] Randomized double-blind placebo-controlled donepezil augmentation in antidepressant-treated elderly patients with depression and cognitive impairment: a pilot studyINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 7 2008Gregory H. Pelton Abstract Objective To assess combined antidepressant and cognitive enhancer treatment in elderly patients presenting with depression plus cognitive impairment. Methods Twenty-three elderly (>50 years old) depressed, cognitively impaired (DEP-CI) patients participated in a pilot study. We evaluated whether, after 8 weeks of open antidepressant treatment, donepezil HCl (Aricept) would afford added cognitive benefit compared to placebo in a randomized 12-week trial. A subsample continued in an 8-month extension phase of open treatment with donepezil. Neuropsychological testing (NPT) was performed and antidepressant response monitored at baseline and the 8, 20, and 52-week time points. Results At 8-weeks, the antidepressant response rate was 61% (14/23). Improvement in SRT immediate recall (SRT-IR; e.g. episodic verbal memory) was observed in responders compared to non-responders. During the 12-week, placebo-controlled, donepezil add-on trial, patients on donepezil showed further improvement in SRT-IR versus patients on placebo. In the open extension phase, patients who continued open donepezil treatment (n,=,6) maintained improvement in memory and tended to show an advantage over patients who never received donepezil and were evaluated at the 52-week time point (n,=,6). There were no observed significant donepezil effects on non-memory cognitive domains. Conclusion These preliminary findings suggest that addition of a cholinesterase inhibitor (AChEI) following antidepressant medication treatment in elderly Dep-CI patients may improve cognition, and support the need for a confirmatory, larger randomized placebo-controlled trial. Copyright © 2007 John Wiley & Sons, Ltd. [source] Untersuchungen zum Einfluß einer Xylanaseergänzung in Legehennenrationen auf Weizenbasis 2.JOURNAL OF ANIMAL PHYSIOLOGY AND NUTRITION, Issue 1-2 2000Mitteilung: Auswirkungen auf die Leistungsparameter Summary The influence of a xylanase supplement on performance of laying hens fed different energy-graded, wheat-based rations was tested in a 12-week trial. Two varieties of wheat with different extraction viscosity were selected. In addition to the control ration, three test rations with reduced energy contents of ,3, ,6, and ,9% were used. Sixteen groups, each consisting of 30 hens were kept in single cages. At the beginning of the experiment hens were 24 weeks old. Single eggmass and daily eggmass production showed a statistically significant difference. This was not caused by the enzyme supplement or the energy content, but by the variety of wheat. Interaction effects between variety of wheat, enzyme supplement and energy content became obvious with regard to the yolk colour. The influence of the enzyme on the yolk colour is positive and statistically highly significant. Thus, the addition of xylanase to wheat-based rations does not affect the performance parameters of laying hens positively. Zusammenfassung In einem zwölfwöchigem Leistungsversuch wurde der Einfluß einer Xylanaseergänzung in Legehennenrationen auf Weizenbasis mit abgestuftem Energiegehalt auf die Leistungsparameter untersucht. Dazu wurden zwei Weizensorten (Alidos + Caprimus) mit unterschiedlicher Extraktviskosität ausgesucht und neben den jeweiligen Kontrollrationen drei Versuchsrationen mit abgestuftem Energiegehalt (,3%, ,6%, ,9%) eingesetzt. Den 16 Versuchsgruppen waren jeweils 30 Legehennen zugeordnet, die bei Versuchsbeginn 24 Lebenswochen alt waren. Es handelte sich um eine Einzelkäfigaufstallung. Statistisch signifikante Unterschiede ergaben sich bei der Einzeleimasse und der täglichen Eimasseproduktion, die sich jedoch weder dem Enzymzusatz noch dem Energiegehalt zuordnen ließen, sondern durch die Weizensorte bedingt waren. Es zeigten sich Wechselwirkungen zwischen Weizensorte, Enzymsupplementierung und Energiegehalt auf die Dotterfarbe. Es war ein statistisch hochsignifikanter positiver Enzymeinfluß auf die Dotterfarbe zu erkennen. Insgesamt gesehen, zeigte sich auch in diesem Legehennenversuch keine positive Wirkung der Xylanaseergänzung auf die Leistungsparamter zu Rationen auf Weizenbasis. [source] Efficacy and safety of a new clobetasol propionate 0.05% foam in alopecia areata: a randomized, double-blind placebo-controlled trialJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 10 2006Antonella Tosti Abstract Background, Clinical efficacy of topical corticosteroids in alopecia areata (AA) is still controversial. Positive clinical results have been obtained using ointments with occlusive dressing but this approach has a low patient compliance. Recently, a new topical formulation (thermophobic foam: Versafoam®) of clobetasol propionate 0.05% has been introduced on the market (Olux®, Mipharm, Milan, Italy) (CF). This formulation is easy to apply. After application to the skin the foam quickly evaporates without residues and it has a good patient compliance. In vitro studies have also shown that this formulation enhances the delivery of the active compound through the skin. Aim, To evaluate the efficacy, safety and tolerability of CF in the treatment of moderate to severe AA. Subjects and methods, Thirty-four patients with moderate to severe AA (eight men, mean age 40 ± 13 years) were enrolled in a randomized, double-blind, right-to-left, placebo-controlled, 24-week trial. Alopecia grading score (AGS) was calculated at baseline and after 12 and 24 weeks of treatment using a 0,5 score (0 = no alopecia; 5 = alopecia totalis). Clobetasol foam and the corresponding placebo foam (PF) were applied twice a day for 5 days/week for 12 weeks (phase 1) using an intrapatient design (right vs. left). From weeks 13 to 24 each enrolled patient continued only with the treatment (both on the right and left site) that was judged to have a greater efficacy than that on the contralateral side (phase 2). The primary outcome of the trial, evaluated on an intention-to-treat basis, was the hair regrowth rate, which was evaluated using a semiquantitative score (RGS) (from 0: no regrowth, to 4: regrowth of 75%). Results, At baseline the AGS was 4.1 (range: 2,5). Nine (26%) patients prematurely concluded the trial. At the end of phase 1, a greater hair regrowth was observed in 89% of the head sites treated with CF vs. 11% in the sites treated with PF. The RGS was 1.2 ± 1.6 in the CF-treated sites and 0.4 ± 0.8 in the PF-treated sites (P = 0.001). A RGS of 2 (hair regrowth of more than 25%) was observed in 42% CF-treated sites and in 13% of PF-treated sites (P = 0.027). In seven subjects (20%) a RGS of 3 to 4 (hair regrowth of 50%) was observed in CF-treated sites. In three subjects (9%) a RGS of 4 (hair regrowth of 75%) was observed in CF-treated sites. In one patient only, in a PF-treated region, a RGS of 3 was observed. The AS was reduced to 3.8 by CF treatment at the end of phase 1 and to 3.3 at the end of phase 2 (P = 0.01). From weeks 12 to 24 the treatment with CF induced a further increase in the RGS (from 1.2 to 1.5 ± 1.4). Forty-seven per cent of CF-treated patients had a RGS of 2 at the end of the trial. A total of eight patients (25%) at the end of the treatment with CF showed a RGS of 3. Folliculitis occurred in two patients. No significant modifications in cortisol and ACTH blood levels were observed during the trial. Conclusion, This new formulation of clobetasol propionate foam is an effective, safe and well-tolerated topical treatment for AA. This formulation has a good cosmetic acceptance and patient compliance profile. [source] An open-labelled study of granulocyte colony-stimulating factor in the treatment of active Crohn's diseaseALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2005J. R. Korzenik Summary Background :,Immunodeficiency syndromes associated with a Crohn's-like illness suggest innate immune defects may lead to Crohn's disease. Anecdotal cases using haemopoietic colony-stimulating factors report improvement in intestinal disease associated with these syndromes. Aim :,To test the safety and efficacy of recombinant human granulocyte colony-stimulating factor in active Crohn's disease. Methods :,In an open-labelled 12-week trial, patients with a Crohn's Disease Activity Index between 220 and 450 were treated with recombinant human granulocyte colony-stimulating factor (filgrastim, Neupogen). Concomitant immunosuppressants were prohibited except prednisone ,20 mg/day. Patient's received recombinant human granulocyte colony-stimulating factor 300 mcg daily subcutaneously adjusted to achieve an absolute neutrophil count between 25 and 35 × 109/L. Results :,Twenty patients were enrolled with a mean initial Crohn's Disease Activity Index of 307 (range: 234,428). Fifteen patients (75%) completed 8 weeks; 13 patients (65%) completed 12 weeks with the mean Crohn's Disease Activity Index for patients continuing through those times of 196 (range: 36,343) and 162 (range: 20,308), respectively. At week 12, 11 patients (55%) demonstrated a decrease of at least 70 points; five (25%) achieved a sustained remission. The mean decrease was statistically significant at each assessment time-point. Three of four patients with fistulae had a positive response. Adverse effects included bone pain, mostly mild resolving with continued treatment. One patient was hospitalized with a viral-like syndrome but it is uncertain if this was treatment related. Conclusion :,Recombinant human granulocyte colony-stimulating factor is safe and potentially effective therapy for active Crohn's disease. [source] Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegalyCLINICAL ENDOCRINOLOGY, Issue 2 2008Philippe Chanson Summary Background, An essential criterion for control of acromegaly is normalization of IGF-I levels. Somatostatin analogues act to suppress IGF-I and GH levels. Objective, To assess the efficacy and safety of 48 weeks titrated dosing of lanreotide Autogel. Design, Open-label, multicentre, phase III, 48-week trial. Methods, Patients with active acromegaly (IGF-I levels > 1·3 times upper limit of age-adjusted normal range) were recruited. Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels. Intention-to-treat analysis was performed to determine the proportion of patients with normalized age-adjusted IGF-I levels at study end. Secondary evaluations included GH levels, clinical acromegaly signs and safety. Results, Fifty-seven of 63 patients completed the study. Lanreotide Autogel resulted in normalized age-adjusted IGF-I levels in 27 patients (43%, 95% CI 31,55). Mean GH levels decreased from 6·2 to 1·5 µg/l at study end, with 53 of 62 patients (85%) having GH levels , 2·5 µg/l (95% CI 76·7,94·3) and 28 of 62 patients (45%) with levels < 1 µg/l (95% CI 32·8,57·6). Twenty-four (38%) had both normal IGF-I levels and GH levels , 2·5 µg/l. Acromegaly symptoms reduced significantly in most patients throughout the study. The most common adverse events were gastrointestinal, as expected for somatostatin analogues. Conclusions, Using IGF-I as primary end-point, 48 weeks lanreotide Autogel treatment, titrated for optimal hormonal control, controlled IGF-I and GH levels effectively, reduced acromegaly symptoms and was well tolerated. [source] | ||||||||||