Randomized controlled trial

About: Randomized controlled trial is a research topic. Over the lifetime, 119828 publications have been published within this topic receiving 4861808 citations. The topic is also known as: RCT & randomized control trial.

Fluoxetine for acute treatment of depression in children and adolescents: a placebo-controlled, randomized clinical trial.

Abstract: Background: This report presents results from the acute treatment phase of a clinical trial designed to confirm efficacy of a fixed dose of 20 mg of fluoxetine in children and adolescents with major depressive disorder (MDD). Method: After a 3-week screening period, 122 children and 97 adolescents with MDD ( DSM-IV ) were randomly assigned to placebo or fluoxetine. After a 1-week placebo lead-in, fluoxetine-treated patients received fluoxetine 10 mg/day for 1 week, then fluoxetine 20 mg/day for 8 weeks. Results: Fluoxetine was associated with greater mean improvement in Children's Depression Rating Scale-Revised (CDRS-R) score than placebo after 1 week ( p p p = .093). Significantly more fluoxetine-than placebo-treated patients completed acute treatment ( p = .001). There were no significant differences between treatment groups in discontinuations due to adverse events ( p = .408). Conclusions: Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of MDD in child and adolescent outpatients. Fluoxetine is the only antidepressant that has demonstrated efficacy in two placebo-controlled, randomized clinical trials of pediatric depression.

A behavioral approach to achieving initial cocaine abstinence.

Abstract: Objective: The aim ofthis study was to assess the efficacy ofa behavioral treatment program f or achieving initial cocaine abstinence in individuals enrolled in outpatient treatment for cocaine dependence. Method: Thirteen consecutively admitted outpatients were offered behavioral treatment consisting of contingency management procedures and the community reinforcement approach. Fifteen consecutively admitted outpatients were offered treatment with 12-step counseling. All 13 of the patients who were offered the behavioral treatment accepted it; 12 ofthe patients offered 12-step counseling accepted it. Results: Eleven ofthe 13 patients in the behavioral treatment were retained for 12 weeks of treatment, compared with five of the I 2 patients given 12-step counseling. Ten of the patients given behavioral therapy achieved 4 weeks of continuous cocaine abstinence, compared with only three of those given 1 2-step counseling. Six of the patients in the behavioral treatment group achieved 8 weeks, and three achieved 12 weeks; none ofthe patients in the 12-step counseling program achieved 8 weeks. Conclusions: The behavioral treatment described in this paper offers promise as an effective intervention for achieving initial cocaine abstinence. A randomized trial is underway to assess the generality of these findings. (AmJ Psychiatry1991; 148:1218-1224)

Lithium in the Prevention of Suicidal Behavior and All-Cause Mortality in Patients With Mood Disorders: A Systematic Review of Randomized Trials

Abstract: Objective: Observational studies suggest that long-term lithium treatment has a strong antisuicidal effect in mood disorders, but it is uncertain whether this association is a genuine therapeutic effect or is due to confounding factors in nonrandomized studies. The authors conducted a systematic review and meta-analysis of randomized trials to investigate the effect of lithium, compared to placebo and other active treatments, on the risk of suicide, deliberate self-harm, and all-cause mortality in patients with mood disorder. Method: The data source was the Cochrane Collaboration Depression, Anxiety

A randomized trial of dialectical behavior therapy versus general psychiatric management for borderline personality disorder.

Abstract: Objective: The authors sought to evaluate the clinical efficacy of dialectical behavior therapy compared with general psychiatric management, including a combination of psychodynamically informed therapy and symptom-targeted medication management derived from specific recommendations in APA guidelines for borderline personality disorder. Method: This was a single-blind trial in which 180 patients diagnosed with borderline personality disorder who had at least two suicidal or nonsuicidal self-injurious episodes in the past 5 years were randomly assigned to receive 1 year of dialectical behavior therapy or general psychiatric management. The primary outcome measures, assessed at baseline and every 4 months over the treatment period, were frequency and severity of suicidal and nonsuicidal self-harm episodes. Results: Both groups showed improvement on the majority of clinical outcome measures after 1 year of treatment, including significant reductions in the frequency and severity of suicidal and nonsuicidal ...