Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

Depressive Disorder, Major Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824291
• Other study ID #: 3151A1-4415
• Secondary ID: B2061006
• Status: Completed
• Phase: Phase 3
• First received: January 14, 2009
• Last updated: March 4, 2011
• Start date: February 2009
• Est. completion date: November 2009

Study information

• Verified date: March 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 74 Years

Eligibility

Inclusion Criteria:

• Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.

• Employed for 20 hours or more for a minimum of 1 month prior to baseline.

• Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

Exclusion Criteria:

• Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.

• Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of >=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).

• Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.

• Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• desvenlafaxine succinate sustained release
50 mg/day oral tablet for 12 weeks

Genetic:
• Genotyping
CYP2D6 genotyping at randomization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12	HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.	At Baseline and Week 12.	No
Secondary	Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12	Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10.	At Baseline and Week 12.	No
Secondary	Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12	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. Higher score = more affected. Change = score at observation minus score at baseline.	At Baseline and Week 12.	No
Secondary	Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12	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 = more affected. Change: score at observation minus score at baseline.	At Baseline and Week 12.	No
Secondary	Change From Baseline on Work and Activities Item of HAM-D17 at Week 12	The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.	At Baseline and Week 12.	No
Secondary	Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12	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).	At Baseline and Week 12.	No
Secondary	Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12	WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.	At Baseline and Week 12.	No
Secondary	Change From Baseline on Stress and Social Support Scales at Week 12	Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.	At Baseline and Week 12.	No

External Links

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