A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder

Pfizer57 sites in 1 country924 target enrollmentOctober 2011

Interventionsdesvenlafaxine succinate sustained-release 100 mg/day placebo desvenlafaxine succinate sustained-release 50 mg/day

Drugsdesvenlafaxine succinate sustained-release 50 mg/day desvenlafaxine succinate sustained-release 100 mg/day placebo

Overview

Phase: Phase 4
Intervention: desvenlafaxine succinate sustained-release 100 mg/day
Conditions: Major Depressive Disorder
Sponsor: Pfizer
Enrollment: 924
Locations: 57
Primary Endpoint: Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

August 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
•A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
•A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

Exclusion Criteria

•Significant risk of suicide based on clinical judgment.
•Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
•Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
•History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
•Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.

Arms & Interventions

desvenlafaxine succinate sustained-release 100 mg/day

Intervention: desvenlafaxine succinate sustained-release 100 mg/day

Placebo

Intervention: placebo

desvenlafaxine succinate sustained-release 50 mg/day

Intervention: desvenlafaxine succinate sustained-release 50 mg/day

Outcomes

Primary Outcomes

Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8

Time Frame: Baseline to Week 8 (final on-therapy)

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline

Secondary Outcomes

Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score(Baseline to Week 8 (final on-therapy))
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate(Baseline to Week 8 (final on-therapy))
Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate(Baseline to week 8 (final on-therapy))
Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score(Baseline to Week 8 (final on-therapy))
Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)(Baseline to Week 8 (final on-therapy))
Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)(Baseline to Week 8 (final on-therapy))