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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Desvenlafaxine Succinate Sustained-Release (DVS SR) (Drug); Desvenlafaxine Succinate Sustained-Release (DVS SR) (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

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

Secondary outcome:

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

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

Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)

Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)

Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)

Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)

Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)

Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Pfizer Investigational Site, Fukuoka 8100001, Japan

Pfizer Investigational Site, Fukuoka 8100041, Japan

Pfizer Investigational Site, Fukushima 9600102, Japan

Pfizer Investigational Site, Hiroshima 7310121, Japan

Pfizer Investigational Site, Kumamoto 8618002, Japan

Pfizer Investigational Site, Kumamoto 8620909, Japan

Pfizer Investigational Site, Kyoto 6168421, Japan

Pfizer Investigational Site, Osaka 5420006, Japan

Pfizer Investigational Site, Saitama 33000062, Japan

Pfizer Investigational Site, Saitama 3390057, Japan

Pfizer Investigational Site, Nagoya, Aichi 4530015, Japan

Pfizer Investigational Site, Toyoake, Aichi 4701192, Japan

Pfizer Investigational Site, Arcadia, California 91007, United States

Pfizer Investigational Site, Beverly Hills, California 90210, United States

Pfizer Investigational Site, Cerritos, California 90703, United States

Pfizer Investigational Site, Garden Grove, California 92845, United States

Pfizer Investigational Site, Los Alamitos, California 90720, United States

Pfizer Investigational Site, Noda, Chiba 2780033, Japan

Pfizer Investigational Site, St. Petersburg, Florida 33702, United States

Pfizer Investigational Site, Kitakyusyu, Fukuoka 8020006, Japan

Pfizer Investigational Site, Kitakyusyu, Fukuoka 8078555, Japan

Pfizer Investigational Site, Shirakawa, Fukushima 9610021, Japan

Pfizer Investigational Site, Atlanta, Georgia 30328, United States

Pfizer Investigational Site, Smyrna, Georgia 30080, United States

Pfizer Investigational Site, Fujioka, Gunma 3750017, Japan

Pfizer Investigational Site, Kumagaya, Gunma 3600032, Japan

Pfizer Investigational Site, Hatsukaichi, Hiroshima 7380023, Japan

Pfizer Investigational Site, Kure, Hiroshima 7370023, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 0028029, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 0040052, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 0600061, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 600042, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 630804, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 630061, Japan

Pfizer Investigational Site, Kobe, Hyogo 6530841, Japan

Pfizer Investigational Site, Libertyville, Illinois 60048, United States

Pfizer Investigational Site, Kanazawa, Ishikawa 9208650, Japan

Pfizer Investigational Site, Minamiashigara, Kanagawa 2500136, Japan

Pfizer Investigational Site, Yokohama, Kanagawa 2200004, Japan

Pfizer Investigational Site, Yokohama, Kanagawa 2210835, Japan

Pfizer Investigational Site, Yokohama, Kanagawa 2250012, Japan

Pfizer Investigational Site, Yatsushiro, Kumamoto 8660043, Japan

Pfizer Investigational Site, Matsumoto, Nagano 3908510, Japan

Pfizer Investigational Site, Dayton, Ohio 45408, United States

Pfizer Investigational Site, Sakai, Osaka 5900018, Japan

Pfizer Investigational Site, East Providence, Rhode Island 02914, United States

Pfizer Investigational Site, Kanzaka, Saga 8420192, Japan

Pfizer Investigational Site, Misato, Saitama 3410018, Japan

Pfizer Investigational Site, Kusatsu, Shiga 5250037, Japan

Pfizer Investigational Site, Columbia, South Carolina 29201, United States

Pfizer Investigational Site, Memphis, Tennessee 38117, United States

Pfizer Investigational Site, Dallas, Texas 75230, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Bunkyo, Tokyo 1120012, Japan

Pfizer Investigational Site, Chiyoda, Tokyo 1000006, Japan

Pfizer Investigational Site, Chiyoda, Tokyo 1018643, Japan

Pfizer Investigational Site, Itabashi, Tokyo 1730004, Japan

Pfizer Investigational Site, Katsushika, Tokyo 1250041, Japan

Pfizer Investigational Site, Kodaira, Tokyo 1858551, Japan

Pfizer Investigational Site, Minato, Tokyo 1070052, Japan

Pfizer Investigational Site, Nakano, Tokyo 1640012, Japan

Pfizer Investigational Site, Setagaya-ku, Tokyo 1540004, Japan

Pfizer Investigational Site, Setagaya, Tokyo 1540012, Japan

Pfizer Investigational Site, Shibuya, Tokyo 1500001, Japan

Pfizer Investigational Site, Shibuya, Tokyo 1510053, Japan

Pfizer Investigational Site, Shinagawa, Tokyo 1410021, Japan

Pfizer Investigational Site, Shinagawa, Tokyo 1410022, Japan

Pfizer Investigational Site, Shinagawa, Tokyo 1420021, Japan

Pfizer Investigational Site, Shinjyuku, Tokyo 1600023, Japan

Pfizer Investigational Site, Suginami, Tokyo 1660003, Japan

Pfizer Investigational Site, Taito, Tokyo 1100003, Japan

Pfizer Investigational Site, Toshima, Tokyo 1700002, Japan

Pfizer Investigational Site, Meguro, Toyko 1520012, Japan

Pfizer Investigational Site, Salt Lake City, Utah 84107, United States

Pfizer Investigational Site, Kirkland, Washington 98033, United States

Pfizer Investigational Site, Seattle, Washington 98104, United States

Pfizer Investigational Site, Brown Deer, Wisconsin 53223, United States

Pfizer Investigational Site, Ube, Yamaguchi 7558505, Japan

Additional Information

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

Starting date: December 2008
Last updated: June 8, 2011

Page last updated: August 23, 2015

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