International clinical psychopharmacology
-
Int Clin Psychopharmacol · Nov 2007
Randomized Controlled Trial Multicenter StudyA randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in the treatment of major depressive disorder.
The antidepressant efficacy and safety of desvenlafaxine succinate (desvenlafaxine) were evaluated in a phase III, double-blind, placebo-controlled study. Outpatients with a primary diagnosis of major depressive disorder were treated with fixed once-daily doses of desvenlafaxine 200 or 400 mg for 8 weeks. The primary efficacy measure was change from baseline on the 17-item Hamilton Rating Scale for Depression. ⋯ Desvenlafaxine 400 mg/day was significantly better than placebo on selected Visual Analog Scale-Pain Intensity subscale scores. Most adverse events were mild or moderate in severity, and safety assessments revealed few clinically significant changes in vital signs, laboratory tests, and electrocardiogram results. These data provide support for the efficacy and safety of desvenlafaxine in the treatment of major depressive disorder.
-
Int Clin Psychopharmacol · Mar 2007
Randomized Controlled TrialA 12-week, double-blind, placebo-controlled trial of galantamine adjunctive treatment to conventional antipsychotics for the cognitive impairments in chronic schizophrenia.
The objective of the study was to study the effects of acetylcholinesterase inhibitors on cognition in patients with schizophrenia. We conducted a 12-week, double-blind, placebo-controlled trial of galantamine as adjunctive treatment to conventional antipsychotic drugs on 24 patients with schizophrenia. The 24 patients had been stabilized on conventional antipsychotic drugs (chlorpromazine equivalent dose of 1390 mg/day) for a minimum of 3 months before their enrollment into the study. ⋯ Of the several domains of cognitive functions assessed, galantamine tended to improve the score for recognition on the Hopkins Verbal Learning Test and for color on the Stroop Test (P<0.1), but these results were not statistically significant. The scores on the Korean version of Mini Mental State Examination did not change significantly in patients with galantamine, and the psychiatric symptoms did not change. The addition of galantamine to the conventional antipsychotic medication of patients with schizophrenia does not produce a change in the cognitive function or state of psychopathology.
-
Int Clin Psychopharmacol · Jan 2006
Randomized Controlled Trial Multicenter StudyAn open-label extension trial of risperidone monotherapy in the treatment of bipolar I disorder.
The primary objective of this 9-week open-label extension trial was to assess the effects of risperidone monotherapy in patients with acute bipolar I disorder who completed treatment in two preceding 3-week double-blind trials. Patients with DSM-IV bipolar I disorder, experiencing an acute manic episode, received a flexible dose of risperidone (1-6 mg/day) or placebo in two independent double-blind, randomized, 3-week monotherapy trials. Completers who required ongoing treatment were eligible to enter this open-label 9-week extension trial during which all patients received risperidone. ⋯ Risperidone treatment was well tolerated and resulted in further improvement during the 9-week extension, beyond the 3 weeks of acute treatment. Patients switched from placebo to risperidone improved markedly. Risperidone treatment did not induce depression.
-
Int Clin Psychopharmacol · Nov 2005
Randomized Controlled Trial Comparative StudyAmisulpride versus quetiapine for the treatment of delirium: a randomized, open prospective study.
The present study aimed to: (i) provide preliminary data on the effectiveness and tolerability of atypical antipsychotics, amisulpride (AMSP) and quetiapine (QTP) for patients with delirium and (ii) investigate whether the two drugs affect sleep differently and further relation with the recovery time of delirium. Forty patients with delirium were randomly assigned to either AMSP or QTP groups, with a flexible dosing schedule. The Delirium Rating Scale-revised-98 (DRS-R-98) and clinical global impression-severity (CGI-S), total sleep time and quality of sleep were assessed daily. ⋯ Both atypical antipsychotics were generally well tolerated. The present study shows that both amisulpride and quetiapine may be useful drugs for the treatment of delirium on the basis of effectiveness and relative lack of adverse events. Further systematic controlled studies are required.
-
Int Clin Psychopharmacol · May 2004
Randomized Controlled Trial Comparative Study Clinical TrialThe cost-effectiveness of mirtazapine versus paroxetine in treating people with depression in primary care.
Currently, there are no data available comparing cost-effectiveness of two antidepressants in the primary care setting in the UK. Alongside a randomized, double-blind, 24-week study of mirtazapine and paroxetine, data were prospectively collected on patients' use of hospital and non-hospital services and days off work. Costs were estimated in each treatment arm from National Health Service (NHS) and societal perspectives, and were compared with selected outcome measures (numbers of 17-item Hamilton Rating Scale for Depression (17-HAMD) responders and changes in Quality of Life in Depression Scale scores between baseline and 24-week endpoint) to explore and compare relative cost-effectiveness. ⋯ Mean total NHS costs per patient were also lower (120 pounds) with mirtazapine (1408 pounds) compared to paroxetine (1528 pounds). The advantage for mirtazapine remained present on all variables analysed after performing sensitivity analyses. The results suggest that mirtazapine may be a cost-effective treatment choice compared to paroxetine for depression in a primary care setting.