A randomized, double-blind, active-control study of sertraline versus venlafaxine XR in major depressive disorder.

Objective: Sertraline may produce dual neurotransmitter effects similar to the serotonin-norepinephrine reuptake inhibitors (SNRIs); however, it has been tested against an SNRI in only 1 previous study, and never at an optimal dose. The objective of the current multisite study was to compare relatively higher doses of sertraline (i.e.

High-dose sertraline strategy for nonresponders to acute treatment for obsessive-compulsive disorder: a multicenter double-blind trial.

Objective: To evaluate the efficacy and safety of high-dose sertraline for patients with obsessive-compulsive disorder (OCD) who failed to respond to standard sertraline acute treatment.

Method: Sixty-six nonresponders to 16 weeks of sertraline treatment who met DSM-III-R criteria for current OCD were randomly assigned, in a double-blind continuation phase of a multicenter trial, either to continue on 200 mg/day of sertraline or to increase their dose to between 250 and 400 mg/day for 12 additional weeks. Efficacy measures included the Yale-Brown Obsessive Compulsive Scale (YBOCS), the National Institute of Mental Health Global Obsessive Compulsive Scale (NIMH Global OC Scale), and the Clinical Global Impressions-Severity of Illness and -Improvement (CGI-I) scales.

Efficacy and safety of 30 mg/d and 45 mg/d nemifitide compared to placebo in major depressive disorder.

Nemifitide is a novel pentapeptide antidepressant, which appears to be effective in the treatment of major depressive disorder (MDD). In the present study 81 patients with MDD, DSM-IV criteria were randomized following a 1-wk screening period to receive 30 mg/d nemifitide, 45 mg/d nemifitide or placebo in a 6-wk double-blind, multicentre, outpatient efficacy study. Nemifitide or placebo was delivered by subcutaneous injection for 2 wk daily for 5 days (Monday to Friday) in the first 2 wk and patients were followed up for a further 4 wk.

Double-blind comparison of citalopram and placebo in depressed outpatients with melancholia.

This multicenter study compared the efficacy and safety of citalopram and placebo in a population of moderately to severely depressed patients with melancholia. This randomized, double-blind, parallel-group study compared citalopram (flexible dose; 20-80 mg/day) with placebo in 180 psychiatric outpatients with a DSM-III diagnosis of major depression or bipolar disorder, depressed, who also met DSM-III criteria for melancholia. Following a 1-week placebo washout period, patients meeting study entry criteria were randomized to 4 weeks of double-blind treatment with either citalopram or placebo.

A double-blind comparison of fluvoxamine and paroxetine in the treatment of depressed outpatients.

Background: Fluvoxamine and paroxetine, both serotonin selective reuptake inhibitors (SSRIs), were compared at two centers in a 7-week double-blind study in outpatients with major depression, diagnosed by DSM-III-R criteria.

Method: Sixty patients were randomly assigned to receive dosage titrated upward to between 50-150 mg/day of fluvoxamine (N = 30) or 20-50 mg/day of paroxetine (N = 30). The mean +/- SD daily dose administered at the last assessment was 102 +/- 44 mg/day for fluvoxamine and 36 +/- 13 mg/day for paroxetine.

Management of clinical trials with new medications for cocaine dependence and abuse.

Clinical trials require a quite distinct shift in attitudes and procedures from ordinary clinical practice insofar as they require a proactive approach to patient recruitment, enrollment, and followthrough as well as significant attention paid to issues of documentation, regulatory compliance, and error prevention. Take documentation, for example: Today's requirement to have an independent record of clinical events that are recorded on the case report forms was until 5 or 7 years ago not addressed in as much detail as it is today. This is one of the first adjustments that the new investigator must address.

Nefazodone versus sertraline in outpatients with major depression: focus on efficacy, tolerability, and effects on sexual function and satisfaction.

Background: The efficacy, tolerability, and effects on sexual function and satisfaction of nefazodone and sertraline were compared in a multicenter, randomized, double-blind, parallel-group study in outpatients with major depression.

Method: One hundred sixty patients, 18 years of age or older, who met DSM-III-R criteria for single or recurrent nonpsychotic major depressive episodes were randomly assigned to 6 weeks of treatment with either nefazodone (100-600 mg/day) or sertraline (50-200 mg/day). Symptoms were assessed before and during treatment using the 17-item Hamilton Rating Scale for Depression (HAM-D-17), Clinical Global Impressions (CGI) Improvement scale, the CGI Severity of Illness scale, and a sexual function questionnaire.

Long-term safety and clinical acceptability of venlafaxine and imipramine in outpatients with major depression.

The antidepressant efficacy and safety of venlafaxine was shown previously in 6-week, placebo-controlled trials. We evaluated the long-term safety and clinical acceptability of venlafaxine and imipramine in a double-blind, parallel-group, comparative study. Two hundred ninety depressed outpatients were treated with venlafaxine, and an additional 91 received imipramine for as long as clinically necessary, up to 1 year.

The cardiovascular effects of bupropion and nortriptyline in depressed outpatients.

The cardiovascular effects of bupropion hydrochloride and nortriptyline were compared in a double-blind, randomized, 6-week trial in adult outpatients with major depression. After a 1-week placebo phase, 58 patients were randomized to treatment with bupropion (225-450 mg/day) and 57 to nortriptyline (75-150 mg/day). Nortriptyline-treated patients had statistically significant heart rate increases at each assessment as determined by RR intervals on electrocardiogram (14.

A comparison of paroxetine and placebo in depressed outpatients.

To compare the safety and efficacy of paroxetine (n = 167) and placebo (n = 169), data from 4 centres using the same protocol were pooled. A double-blind parallel group design was used, with therapy lasting 6 weeks. Significant differences between paroxetine- and placebo-treated patients were found on the major efficacy outcome variables by week 2 and on all efficacy variables by week 4 of the study.

Paroxetine versus placebo: a double-blind comparison in depressed patients.

Background: Paroxetine is a potent and selective serotonin reuptake inhibitor (SSRI). The present study assessed the efficacy and tolerability of paroxetine against placebo in depressed outpatients.

Method: A double-blind, parallel-group study was undertaken in four stand-alone centers.

A double-blind, placebo-controlled study of paroxetine in depressed outpatients.

Paroxetine is an investigational antidepressant that acts through selective inhibition of serotonin reuptake at the synapse. In this study, 81 outpatients with major depression according to DSM-III criteria were treated with either paroxetine or placebo in a 6-week, randomized, double-blind study. Paroxetine was significantly superior to placebo on all major efficacy variables, including depression as well as anxiety, cognitive disturbance, insomnia, psychomotor retardation, and sleep disturbance.

Double-blind, placebo-controlled, fixed dose trial of minaprine in patients with major depression.

Minaprine dihydrochloride is a novel psychotropic drug possessing both antidepressant and psycho-stimulant properties. Prior clinical studies have shown minaprine to be as effective as standard antidepressant agents in the treatment of endogenous depression. The present study examined the safety and efficacy of minaprine at four different doses compared to placebo in 190 outpatients with major depression.

A study of buspirone coprescribed with bronchodilators in 82 anxious ambulatory patients.

This was an open multicenter study wherein patients requiring anxiolytic therapy were treated with buspirone 5 mg t.i.d.

A placebo-controlled multicenter trial of Limbitrol versus its components (amitriptyline and chlordiazepoxide) in the symptomatic treatment of depressive illness.

In a multicenter, placebo-controlled, clinical trial, the efficacy of Limbitrol was compared with that of its components, amitriptyline and chlordiazepoxide. All patients had a diagnosis of primary depression. Data from 279 patients were evaluated using the Hamilton depression scale, the Beck depression inventory, and physician and patient global change measures.

Cultural perspectives on the range of human behavior.

Traditional societies provide a homogeneous world view for everyone, encouraging people to work towards specific objectives. Lack of flexibility in the culturally defined ways of reaching these objectives creates considerable distress for individuals. In rapidly changing urban settings, unlimited modalities create the anxieties which in turn lead people to search for security in unsuitable patterns of belief and behavior.