Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

Pfizer638 enrolled

Overview

The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

638

Conditions

Depressive Disorder, Major

Interventions

Desvenlafaxine Succinate Sustained-Release (DVS SR)DRUG

50 mg tablet, once daily dosing for 8 weeks

Desvenlafaxine Succinate Sustained-Release (DVS SR)DRUG

100 mg tablet, once daily dosing for 8 weeks

PlaceboDRUG

Matching placebo tablets and capsules, once daily dosing for 8 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features. * Depressive symptoms for at least 30 days before the screening visit. * Outpatient men and women at least 18 years of age. Exclusion Criteria: * Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent. * Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation. * 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; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.

Locations (22)

Pfizer Investigational Site

Beverly Hills, California, United States

Outcomes

Primary Outcomes

Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation

HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.

Time frame: Baseline and Week 8 or FOT

Secondary Outcomes

Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.

Time frame: Week 8 or FOT

Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation

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 participants). Higher score = more affected.

Time frame: Baseline and Week 8 or FOT

Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation

MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

Time frame: Baseline and Week 8 or FOT

Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation

Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.

Data from ClinicalTrials.gov

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