Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

NCT00384033 | Completed Phase 3 Results

• 1 other identifier: 3151A1-335
• Study Type: interventional
• Target: 638
• Locations: 1 country
• Sites: 22

Brief Summary

The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.

Conditions

Depressive Disorder, Major

Keywords

MDD; Major Depressive Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation

  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 FOT

Secondary Outcomes (8)

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

  Week 8 or FOT

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

  Baseline and Week 8 or FOT

• Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation

  Baseline and Week 8 or FOT

• Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation

  Baseline and Week 8 or FOT

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

  Baseline and Week 8 or FOT

Study Arms (4)

Desvenlafaxine succinate sustained-release 50 mg

EXPERIMENTAL

Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

Desvenlafaxine succinate sustained-release 100 mg

EXPERIMENTAL

Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Duloxetine 60mg

OTHER

Active control to assess assay sensitivity

Drug: Duloxetine 60 mg/day

Interventions

Desvenlafaxine Succinate Sustained-Release (DVS SR) DRUG

50 mg tablet, once daily dosing for 8 weeks

Desvenlafaxine succinate sustained-release 50 mg

Placebo DRUG

Matching placebo tablets and capsules, once daily dosing for 8 weeks

Placebo

Duloxetine 60 mg/day DRUG

60 mg capsule, once daily dosing for 8 weeks

Duloxetine 60mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
• Depressive symptoms for at least 30 days before the screening visit.
• Outpatient men and women at least 18 years of age.

You may not qualify if:

• Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
• Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
• Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (22)

Pfizer Investigational Site

Beverly Hills, California, 90210, United States

Location

Pfizer Investigational Site

Burbank, California, 91506, United States

Location

Pfizer Investigational Site

Encino, California, 91316, United States

Location

Pfizer Investigational Site

Los Alamitos, California, 90720, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92660, United States

Location

Pfizer Investigational Site

Northridge, California, 91324, United States

Location

Pfizer Investigational Site

Orange, California, 92868, United States

Location

Pfizer Investigational Site

Pasadena, California, 91105, United States

Location

Pfizer Investigational Site

Upland, California, 91786, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

St. Petersburg, Florida, 33702, United States

Location

Pfizer Investigational Site

Edwardsville, Illinois, 62025, United States

Location

Pfizer Investigational Site

Farmington Hills, Michigan, 48336, United States

Location

Pfizer Investigational Site

Flint, Michigan, 48507, United States

Location

Pfizer Investigational Site

Okemos, Michigan, 48864, United States

Location

Pfizer Investigational Site

Clementon, New Jersey, 08021, United States

Location

Pfizer Investigational Site

Dayton, Ohio, 45408, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97210, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19149, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84107, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98104, United States

Location

Pfizer Investigational Site

Brown Deer, Wisconsin, 53223, 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

• Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther. 2009 Jun;31 Pt 1:1405-23. doi: 10.1016/j.clinthera.2009.07.006.

  PMID: 19698901 DERIVED

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 4, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: March 15, 2012
• Results First Posted: March 15, 2012

Record last verified: 2012-02

Locations

US (22)