Journal of clinical psychopharmacology
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J Clin Psychopharmacol · Oct 2005
Randomized Controlled Trial Comparative Study Clinical TrialA Double-blind, randomized trial of St John's wort, fluoxetine, and placebo in major depressive disorder.
This study looks to compare the antidepressant efficacy and safety of a standardized extract of St John's wort with both placebo and fluoxetine. ⋯ St John's wort was significantly more effective than fluoxetine and showed a trend toward superiority over placebo. A (25%) smaller than planned sample size is likely to account for the lack of statistical significance for the advantage (indicating a moderate effect size, d = 0.45) of St John's wort over placebo.
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J Clin Psychopharmacol · Oct 2005
Randomized Controlled Trial Comparative Study Clinical TrialLess impairment on one portion of a driving-relevant psychomotor battery in buprenorphine-maintained than in methadone-maintained patients: results of a randomized clinical trial.
Cognitive impairment in drug-dependent patients under methadone maintenance treatment has been reported before. We assessed whether patients under buprenorphine, a partial mu-opioid agonist, perform better in cognitive tests measuring psychomotor performance as described in previous nonrandomized studies. ⋯ Although there were no differences in cognitive function at baseline, patients under buprenorphine treatment showed partially better results in some of the domains tested. The used tests are relevant when assessing driving ability. There was a significant correlation between dose of buprenorphine and some test results. We also found a correlation between age and reaction time and between duration of opioid dependence and results in some subtests. INTERPRETATIONS (CONCLUSIONS): When comparing both treatments in drug dependent patients, buprenorphine produces partially less impairment on cognitive functions in some of the subtests of the psychomotor battery than methadone. This difference is specially relevant when it comes to driving ability and social functioning.
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J Clin Psychopharmacol · Apr 2005
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy of pregabalin in the treatment of generalized anxiety disorder: double-blind, placebo-controlled comparison of BID versus TID dosing.
Pregabalin is a new anxiolytic that acts as a presynaptic inhibitor of the release of excessive levels of excitatory neurotransmitters by selectively binding to the alpha2-delta subunit of voltage-gated calcium channels. The current study evaluated the anxiolytic efficacy of BID versus TID dosing of pregabalin in patients with generalized anxiety disorder. Outpatients with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition generalized anxiety disorder and having baseline Hamilton Anxiety (HAM-A) total scores > or =20 were randomized to 6 weeks of double-blind treatment with pregabalin 200 mg/d (BID; N = 78), 400 mg/d (BID; N = 89), or 450 mg/d (TID; N = 88) or placebo (N = 86). ⋯ Improvement on both factors was rapid: significance versus placebo was achieved as early as the first assessment at week 1, with > or =30% reduction in HAM-A severity and equal or greater improvement for every subsequent visit in > or =38% of patients in all 3 pregabalin dosage groups (P < or = 0.001). Pregabalin was well tolerated, and despite the fixed-dose study design, discontinuations caused by adverse events ranged from 9% to 13%--comparable with that observed with placebo (8%). This study demonstrates that pregabalin is an effective treatment of generalized anxiety disorder, with BID dosing showing similar efficacy and comparable tolerability with TID dosing.
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J Clin Psychopharmacol · Feb 2005
Randomized Controlled Trial Multicenter Study Clinical TrialRelapse prevention with gepirone ER in outpatients with major depression.
To evaluate long-term efficacy and tolerability of the serotonin 5-HT1A receptor agonist, gepirone extended release (ER), a multicenter, randomized, placebo-controlled relapse prevention study was performed in patients with recurrent major depression (DSM-IV criteria). Patients 18 to 70 years, with a primary diagnosis of recurrent major depression (DSM-IV; 296.3) and a screening and baseline HAMD-17 total score >/=20 were eligible. After a 3- to 14-day (dependent on pretrial medication) single-blind placebo washout period, eligible patients entered an 8- or 12-week (depending on time to remission) open-label gepirone ER treatment period. ⋯ All adverse events occurred in less than 5% of patients with the exception of flu syndrome and headache. In conclusion, gepirone ER at a dose range of 40 to 80 mg/d is effective for relapse prevention in patients with recurrent major depression. It is well tolerated during long-term treatment for up to approximately one year.
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J Clin Psychopharmacol · Apr 2004
Randomized Controlled Trial Multicenter Study Clinical TrialEfficacy of the novel anxiolytic pregabalin in social anxiety disorder: a placebo-controlled, multicenter study.
Pregabalin is a novel compound in development for the treatment of anxiety disorders. The safety and efficacy of pregabalin for the treatment of social anxiety disorder was evaluated in a double-blind, multicenter clinical trial in which 135 patients were randomized to 10 weeks of double-blind treatment with either pregabalin 150 mg/d. pregabalin 600 mg/d, or placebo. The primary efficacy parameter was change from baseline to end point in the Liebowitz Social Anxiety Scale (LSAS) total score. ⋯ Pregabalin 150 mg/d was not significantly better than placebo on any measures. Somnolence and dizziness were the most frequently occurring adverse events among patients receiving pregabalin 600 mg/d. In conclusion, pregabalin 600 mg/d was an effective and well-tolerated treatment of social anxiety disorder.