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

NCT00863798 | Completed Phase 3 Results

• 3 other identifiers: 3151A1-3362B20610053151A1-3362-US
• Study Type: interventional
• Target: 682
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

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

  Week 8 (or ET)

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

  Baseline and Week 8 (or ET )

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

  Baseline and Week 8 (or ET)

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

  Baseline and Week 8 (or ET )

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

  Week 8 (or ET)

Other Outcomes (6)

• Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations

  Week 2, 4 and 8 (or ET)

• Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)

  Baseline and Week 8 (or ET)

• Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)

  Baseline and Week 8 (or ET)

Study Arms (3)

Desvenlafaxine succinate sustained release 10 mg

EXPERIMENTAL

Drug: Desvenlafaxine Succinate Sustained-Release 10mg

Desvenlafaxine succinate sustained release 50 mg

EXPERIMENTAL

Drug: Desvenlafaxine Succinate Sustained-Release 50 mg

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Desvenlafaxine Succinate Sustained-Release 10mg DRUG

10 mg tablet, once daily dosing for 8 weeks

Desvenlafaxine succinate sustained release 10 mg

Desvenlafaxine Succinate Sustained-Release 50 mg DRUG

50 mg tablet, once daily dosing for 8 weeks

Desvenlafaxine succinate sustained release 50 mg

placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead
• Pfizer: collaborator

Study Sites (24)

Pfizer Investigational Site

Birmingham, Alabama, 35216, United States

Location

Pfizer Investigational Site

Encino, California, 91316, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92660, United States

Location

Pfizer Investigational Site

Redlands, California, 92374, United States

Location

Pfizer Investigational Site

Upland, California, 91786, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80045, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80204, United States

Location

Pfizer Investigational Site

Cromwell, Connecticut, 06416, United States

Location

Pfizer Investigational Site

Maitland, Florida, 32751, United States

Location

Pfizer Investigational Site

North Miami, Florida, 33161, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46260, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63139, United States

Location

Pfizer Investigational Site

New York, New York, 10128, United States

Location

Pfizer Investigational Site

Staten Island, New York, 10312, United States

Location

Pfizer Investigational Site

Toledo, Ohio, 43623, United States

Location

Pfizer Investigational Site

Eugene, Oregon, 97401, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97210, United States

Location

Pfizer Investigational Site

Salem, Oregon, 97301, United States

Location

Pfizer Investigational Site

Media, Pennsylvania, 19063, United States

Location

Pfizer Investigational Site

Herndon, Virginia, 20170, United States

Location

Pfizer Investigational Site

Midlothian, Virginia, 23112, United States

Location

Pfizer Investigational Site

Middleton, Wisconsin, 53562, United States

Location

Pfizer Investigational Site

Waukesha, Wisconsin, 53188, United States

Location

Related Publications (7)

• Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.

  PMID: 34183490 DERIVED

• Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.

  PMID: 29140227 DERIVED

• McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.

  PMID: 26709542 DERIVED

• McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.

  PMID: 26644956 DERIVED

• Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.

  PMID: 25758058 DERIVED

• Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.

  PMID: 24571916 DERIVED

• Liebowitz MR, Tourian KA, Hwang E, Mele L; Study 3362 Investigators. A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder. BMC Psychiatry. 2013 Mar 22;13:94. doi: 10.1186/1471-244X-13-94.

  PMID: 23517291 DERIVED

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 6, 2011
• Results First Posted: May 6, 2011

Record last verified: 2011-04

Locations

US (24)