Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of 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 (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798707
• Other study ID #: 3151A1-3359
• Secondary ID: B20610033151A1-3
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2008
• Last updated: June 8, 2011
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: June 2011
• Source: 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 DVS SR (25 and 50 mg/day) in the treatment of 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: 709
• Est. completion date: April 2010
• Est. primary completion date: April 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 judgement, 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 (DVS SR)
25 mg tablet, once daily dosing for 8 weeks
• Desvenlafaxine Succinate Sustained-Release (DVS SR)
50 mg tablet, once daily dosing for 8 weeks
• placebo
Matching placebo tablets (25 or 50 mg). 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
Japan	Pfizer Investigational Site	Bunkyo	Tokyo
Japan	Pfizer Investigational Site	Chiyoda	Tokyo
Japan	Pfizer Investigational Site	Chiyoda	Tokyo
Japan	Pfizer Investigational Site	Fujioka	Gunma
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Fukushima
Japan	Pfizer Investigational Site	Hatsukaichi	Hiroshima
Japan	Pfizer Investigational Site	Hiroshima
Japan	Pfizer Investigational Site	Itabashi	Tokyo
Japan	Pfizer Investigational Site	Kanazawa	Ishikawa
Japan	Pfizer Investigational Site	Kanzaka	Saga
Japan	Pfizer Investigational Site	Katsushika	Tokyo
Japan	Pfizer Investigational Site	Kitakyusyu	Fukuoka
Japan	Pfizer Investigational Site	Kitakyusyu	Fukuoka
Japan	Pfizer Investigational Site	Kobe	Hyogo
Japan	Pfizer Investigational Site	Kodaira	Tokyo
Japan	Pfizer Investigational Site	Kumagaya	Gunma
Japan	Pfizer Investigational Site	Kumamoto
Japan	Pfizer Investigational Site	Kumamoto
Japan	Pfizer Investigational Site	Kure	Hiroshima
Japan	Pfizer Investigational Site	Kusatsu	Shiga
Japan	Pfizer Investigational Site	Kyoto
Japan	Pfizer Investigational Site	Matsumoto	Nagano
Japan	Pfizer Investigational Site	Meguro	Toyko
Japan	Pfizer Investigational Site	Minamiashigara	Kanagawa
Japan	Pfizer Investigational Site	Minato	Tokyo
Japan	Pfizer Investigational Site	Misato	Saitama
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Nakano	Tokyo
Japan	Pfizer Investigational Site	Noda	Chiba
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Saitama
Japan	Pfizer Investigational Site	Saitama
Japan	Pfizer Investigational Site	Sakai	Osaka
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Setagaya	Tokyo
Japan	Pfizer Investigational Site	Setagaya-ku	Tokyo
Japan	Pfizer Investigational Site	Shibuya	Tokyo
Japan	Pfizer Investigational Site	Shibuya	Tokyo
Japan	Pfizer Investigational Site	Shinagawa	Tokyo
Japan	Pfizer Investigational Site	Shinagawa	Tokyo
Japan	Pfizer Investigational Site	Shinagawa	Tokyo
Japan	Pfizer Investigational Site	Shinjyuku	Tokyo
Japan	Pfizer Investigational Site	Shirakawa	Fukushima
Japan	Pfizer Investigational Site	Suginami	Tokyo
Japan	Pfizer Investigational Site	Taito	Tokyo
Japan	Pfizer Investigational Site	Toshima	Tokyo
Japan	Pfizer Investigational Site	Toyoake	Aichi
Japan	Pfizer Investigational Site	Ube	Yamaguchi
Japan	Pfizer Investigational Site	Yatsushiro	Kumamoto
Japan	Pfizer Investigational Site	Yokohama	Kanagawa
Japan	Pfizer Investigational Site	Yokohama	Kanagawa
Japan	Pfizer Investigational Site	Yokohama	Kanagawa
United States	Pfizer Investigational Site	Arcadia	California
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Brown Deer	Wisconsin
United States	Pfizer Investigational Site	Cerritos	California
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	Garden Grove	California
United States	Pfizer Investigational Site	Kirkland	Washington
United States	Pfizer Investigational Site	Libertyville	Illinois
United States	Pfizer Investigational Site	Los Alamitos	California
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Smyrna	Georgia
United States	Pfizer Investigational Site	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HAM-D17 Total Score at the 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. 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

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