International clinical psychopharmacology
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Int Clin Psychopharmacol · Jul 2011
Randomized Controlled Trial Multicenter StudyEfficacy of pregabalin in generalized social anxiety disorder: results of a double-blind, placebo-controlled, fixed-dose study.
The objective of this study was to evaluate the efficacy and tolerability of pregabalin for the treatment of generalized social anxiety disorder (SAD). Patients with generalized SAD, who met the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) criteria (total N=329), were randomly assigned to 11 weeks of double-blind treatment with fixed daily doses of either pregabalin (300, 450, and 600(mg) or placebo. ⋯ The most common adverse events on all three doses of pregabalin were somnolence and dizziness. Consistent with a previous study, the results of this study suggest that the 600-mg dose of pregabalin per day may be efficacious in the treatment of SAD.
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Int Clin Psychopharmacol · Nov 2010
Psychometric evaluation of the Snaith-Hamilton pleasure scale in adult outpatients with major depressive disorder.
The inability to experience pleasure, anhedonia, is recognized as a hallmark symptom of depression. An instrument developed for the assessment of hedonic capacity is the 14-item, self-report, Snaith-Hamilton Pleasure Scale (SHAPS), but its psychometric properties have not been adequately evaluated. This study examined the reliability and validity of the SHAPS using a large sample of adult outpatients with major depressive disorder (MDD). ⋯ Pearson correlations revealed a positive linear relationship between the SHAPS total score and the total scores on the 17-item Hamilton Rating Scale for Depression (r=0.49, P<0.0001), IDS-C30 (r=0.56, P<0.0001), 16-item Quick Inventory of Depressive Symptomatology (r=0.55, P<0.0001), and 10-item clinician-rated Montgomery-Asberg Depression Rating Scale (r=0.53, P<0.0001). The SHAPS total score was negatively correlated with the Quality of Life, Enjoyment, and Satisfaction Questionnaire (r=-0.65, P<0.0001). This study shows that the SHAPS is a reliable, valid, and unidimensional instrument used to assess the hedonic capacity in adult outpatients with MDD.
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Int Clin Psychopharmacol · Nov 2010
Comparative StudyInitial duloxetine prescription dose and treatment adherence and persistence in patients with major depressive disorder.
Adherence and persistence with medication therapy are important in the management of major depressive disorder. This study examined the association between initial prescription dosage of duloxetine and its adherence and persistence. In a large commercial managed-care claims database, 6132 patients with major depressive disorder were initiated on duloxetine between 1 July 2005 and 30 June 2006 at low dose (<60 mg/day, n=1989), mid dose (60 mg/day, n=3733), or high dose (>60 mg/day, n=410). ⋯ Mid-dose duloxetine-initiated patients stayed significantly longer with the medication (107.3 days) compared with low-dose (95.8 days, P<0.01) or high-dose patients (95.4 days, P<0.01). After adjustment for baseline demographics, comorbid conditions, and prior medications, mid-dose initiated patients remained to have better adherence and longer persistence than low-dose or high-dose initiators. The findings suggest that patients initiated with a dose of 60 mg/day of duloxetine seem to be more adherent to and persistent with the medication than those initiated with less or more than 60 mg/day.
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Int Clin Psychopharmacol · Sep 2010
Randomized Controlled Trial Multicenter StudyEfficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study.
This 13-week, double-blind study evaluated the efficacy and safety of the atypical antipsychotic paliperidone palmitate (recently approved in the United States) versus placebo administered as monthly gluteal injections (after two initial doses given 1 week apart) in acutely symptomatic patients with schizophrenia. Patients (N=388) were randomly assigned (1 : 1 : 1 : 1) to paliperidone palmitate 50, 100, or 150 mg eq. or placebo. As the 150 mg eq. dose was administered to fewer patients (n=30) than planned, meaningful and definitive conclusions cannot be drawn from the results of this group. ⋯ The paliperidone palmitate 50 (P=0.004) and 100 mg eq. (P<0.001) groups showed significant improvement in the Personal and Social Performance score from baseline to endpoint versus placebo. Common adverse events (in >or=2% of patients in any group) more frequent with paliperidone palmitate 50 or 100 mg eq. than placebo (>or=5% difference) were headache, vomiting, extremity pain, and injection site pain. Treatment with paliperidone palmitate (100 mg eq.) was efficacious and all doses tested were tolerable.
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Int Clin Psychopharmacol · Sep 2010
Randomized Controlled TrialSilexan, an orally administered Lavandula oil preparation, is effective in the treatment of 'subsyndromal' anxiety disorder: a randomized, double-blind, placebo controlled trial.
This study was performed to investigate the anxiolytic efficacy of silexan, a new oral lavender oil capsule preparation, in comparison to placebo in primary care. In 27 general and psychiatric practices 221 adults suffering from anxiety disorder not otherwise specified (Diagnostic and Statistical Manual of Mental disorders-IV 300.00 or International Statistical Classification of Diseases and Related Health Problems, Tenth revision F41.9) were randomized to 80 mg/day of a defined, orally administered preparation from Lavandula species or placebo for 10 weeks with visits every 2 weeks. A Hamilton Anxiety Scale (HAMA) total score >or=18 and a total score >5 for the Pittsburgh Sleep Quality Index (PSQI) were required. ⋯ Lavandula oil preparation had a significant beneficial influence on quality and duration of sleep and improved general mental and physical health without causing any unwanted sedative or other drug specific effects. Lavandula oil preparation silexan is both efficacious and safe for the relief of anxiety disorder not otherwise specified. It has a clinically meaningful anxiolytic effect and alleviates anxiety related disturbed sleep.