Dataset Information

Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study.

ABSTRACT: OBJECTIVE:To investigate the efficacy, safety, and clinical benefit of a once-daily formulation of trazodone (Trazodone Contramid((c)) OAD) in the treatment of major depressive disorder. DESIGN/PARTICIPANTS:In this double-blind study, 412 patients with major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) were randomized 1:1 to receive either Trazodone Contramid OAD (150 to 375mg) or placebo. Treatment was titrated over two weeks to each individual optimal dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability. MEASUREMENTS:The primary end point was change in the 17-item Hamilton Depression Rating Scale total score from baseline to last study visit. Secondary end points included Hamilton Depression Rating Scale responders/remitters, change in Montgomery-Asberg Depression Rating Scale, Clinician and Patient Global Improvement Scales, and quality of sleep. RESULTS:From the end of titration to the end of the six-week treatment period, the mean maximum daily dose of the intent-to-treat population was 310mg for the active group and 355mg for the placebo group. There was a statistically significant difference between trazodone and placebo on the mean HAMD-17 score (-11.4 vs. -9.3, P=0.012). A significant difference was present as early as Week 1 and was maintained at all subsequent study visits. Many secondary end points supported these findings, including improvements in quality of sleep. The most frequent adverse events were the same for both the treatment and placebo groups: headache and somnolence. There were no serious adverse events that were considered related to treatment. There were no clinically significant electrocardiogram or laboratory abnormalities. CONCLUSIONS:The trazodone Contramid formulation was more effective than placebo in major depressive disorder and was well tolerated.

SUBMITTER: Sheehan DV

PROVIDER: S-EPMC2719441 | biostudies-literature | 2009 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study.

Sheehan David V DV Croft Harry A HA Gossen E Roderich ER Levitt Randy J RJ Brullé Claire C Bouchard Sylvie S Rozova Anna A

Psychiatry (Edgmont (Pa. : Township)) 20090501 5

<h4>Objective</h4>To investigate the efficacy, safety, and clinical benefit of a once-daily formulation of trazodone (Trazodone Contramid((c)) OAD) in the treatment of major depressive disorder.<h4>Design/participants</h4>In this double-blind study, 412 patients with major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) were randomized 1:1 to receive either Trazodone Contramid OAD (150 to 375mg) or placebo. Treatment was titrated over two week ...[more]

PMID: 19724732

Similar Datasets

Project description:BackgroundMajor depressive disorder (MDD) is a serious illness in children and adolescents. Vilazodone is a selective serotonin reuptake inhibitor approved for MDD in adults. This study evaluated the efficacy, safety, and tolerability of vilazodone in adolescent patients, ages 12-17 years, with MDD (NCT01878292).MethodsThis double-blind, randomized, placebo-controlled, parallel-group, fixed-dose study was conducted at 56 study centers in the United States and was 10 weeks in duration (a 1-week screening period, an 8-week double-blind treatment period, and a 1-week double-blind down-taper period). Outpatients with an MDD diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria were included in the study. Clinical inclusion criteria required a Children's Depression Rating Scale-Revised (CDRS-R) total score of ≥ 40 and Clinical Global Impressions-Severity (CGI-S) score of ≥ 4. Patients were randomized 1:1:1 to 8 weeks of double-blind treatment with placebo (n = 174), vilazodone 15 mg/day (n = 175), or vilazodone 30 mg/day (n = 180). The primary and secondary efficacy parameters were change from baseline to week 8 in CDRS-R total score and CGI-S score, respectively. Safety parameters included adverse events (AEs); clinical laboratory, vital sign, and electrocardiogram parameters; and the Columbia-Suicide Severity Rating Scale.ResultsApproximately 86% of patients completed double-blind treatment. There was no statistically significant difference between vilazodone 15 mg/day or 30 mg/day and placebo in change from baseline in CDRS-R score. Change in CGI-S score was not significant after adjustment for multiple comparisons. The most common treatment-emergent AEs were nausea, upper abdominal pain, vomiting, diarrhea, nasopharyngitis, headache, and dizziness. Reports of suicidal ideation (placebo, 33.3%; vilazodone 15 mg/day, 36.0%; vilazodone 30 mg/day, 31.1%) and suicidal behavior (placebo, 1.8%; vilazodone 15 mg/day, 1.1%; vilazodone 30 mg/day, 1.1%) were similar between treatment groups. There were no deaths in the study.ConclusionsThe efficacy of vilazodone for the treatment of MDD in adolescent patients could not be confirmed in this study. Vilazodone was generally safe and well tolerated, with treatment-emergent AEs similar to those in adult patients.Clinical trial registrationNCT01878292.

Dataset Information

Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study.

Publications

Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets