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

Major Depressive Disorder Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863798
• Other study ID #: 3151A1-3362
• Secondary ID: B20610053151A1-3
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2009
• Last updated: April 7, 2011
• Start date: April 2009
• Est. completion date: March 2010

Study information

• Verified date: April 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

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 682
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening).

• Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20.

• Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.

Exclusion Criteria:

• Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from screening to baseline).

• Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.

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
• Major Depressive Disorder

Intervention

Drug:
• Desvenlafaxine Succinate Sustained-Release 10mg
10 mg tablet, once daily dosing for 8 weeks
• Desvenlafaxine Succinate Sustained-Release 50 mg
50 mg tablet, once daily dosing for 8 weeks
• placebo
Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Cromwell	Connecticut
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Herndon	Virginia
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Maitland	Florida
United States	Pfizer Investigational Site	Media	Pennsylvania
United States	Pfizer Investigational Site	Middleton	Wisconsin
United States	Pfizer Investigational Site	Midlothian	Virginia
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	North Miami	Florida
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Redlands	California
United States	Pfizer Investigational Site	Salem	Oregon
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Staten Island	New York
United States	Pfizer Investigational Site	Toledo	Ohio
United States	Pfizer Investigational Site	Upland	California
United States	Pfizer Investigational Site	Waukesha	Wisconsin

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)	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.	Baseline and Week 8 (or ET)	No
Secondary	Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)	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.	Week 8 (or ET)	No
Secondary	Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)	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.	Baseline and Week 8 (or ET )	No
Secondary	Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)	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).	Baseline and Week 8 (or ET)	No
Secondary	Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)	HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.	Baseline and Week 8 (or ET )	No
Secondary	Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)	A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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.	Week 8 (or ET)	No
Secondary	Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)	Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual 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.	Week 8 (or ET)	No
Secondary	Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)	A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It 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).	Week 8 (or ET)	No
Secondary	Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)	CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. 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.	Week 8 (or ET)	No

External Links

•   To obtain contact information for a study center near you, click here.