Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

Pfizer924 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

924

Conditions

Major Depressive Disorder

Interventions

desvenlafaxine succinate sustained-release 50 mg/dayDRUG

50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper

desvenlafaxine succinate sustained-release 100 mg/dayDRUG

100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day

placeboDRUG

50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (61)

Outcomes

Primary Outcomes

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

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.

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

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)

Secondary Outcomes

Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.

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

Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.

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

Data from ClinicalTrials.gov

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Dedicated Clinical Research

Phoenix, Arizona, United States

Deidcated Clinical Research

Phoenix, Arizona, United States

Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

Little Rock, Arkansas, United States

Pacific Clinical Research Medical Group

Arcadia, California, United States

Southwestern Research, Incorporated

Beverly Hills, California, United States

Clinical Innovations, Inc.

Costa Mesa, California, United States

Synergy Clinical Research of Escondido

Escondido, California, United States

Synergy Clinical Research Center

National City, California, United States

Pacific Research Partners

Oakland, California, United States

Pasadena Research Institute, LLC

Pasadena, California, United States

...and 51 more locations

Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score

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

Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate

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. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.

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

Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate

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. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.

Time frame: Baseline to week 8 (final on-therapy)

Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score

The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated. Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function.

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