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

NCT00824291 | Completed Phase 3 Results

• 2 other identifiers: 3151A1-4415B2061006
• Study Type: interventional
• Target: 437
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12

  HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.

  At Baseline and Week 12.

Secondary Outcomes (7)

• Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12

  At Baseline and Week 12.

• Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12

  At Baseline and Week 12.

• Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12

  At Baseline and Week 12.

• Change From Baseline on Work and Activities Item of HAM-D17 at Week 12

  At Baseline and Week 12.

• Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12

  At Baseline and Week 12.

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: desvenlafaxine succinate sustained release

2

EXPERIMENTAL

Genetic: Genotyping

Interventions

desvenlafaxine succinate sustained release DRUG

50 mg/day oral tablet for 12 weeks

Also known as: Pristiq

1

Genotyping GENETIC

CYP2D6 genotyping at randomization

2

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
• Employed for 20 hours or more for a minimum of 1 month prior to baseline.
• Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

You may not qualify if:

• Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
• Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of \>=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
• Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
• Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.

Sponsors & Collaborators

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

Related Publications (9)

• 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

• Reddy S, Fayyad R, Edgar CJ, Guico-Pabia CJ, Wesnes K. The effect of desvenlafaxine on cognitive functioning in employed outpatients with major depressive disorder: a substudy of a randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2016 Jun;30(6):559-67. doi: 10.1177/0269881116631649. Epub 2016 Mar 23.

  PMID: 27009044 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

• Endicott J, Lam RW, Hsu MA, Fayyad R, Boucher M, Guico-Pabia CJ. Improvements in quality of life with desvenlafaxine 50mg/d vs placebo in employed adults with major depressive disorder. J Affect Disord. 2014 Sep;166:307-14. doi: 10.1016/j.jad.2014.05.011. Epub 2014 May 21.

  PMID: 25012446 DERIVED

• Lam RW, Endicott J, Hsu MA, Fayyad R, Guico-Pabia C, Boucher M. Predictors of functional improvement in employed adults with major depressive disorder treated with desvenlafaxine. Int Clin Psychopharmacol. 2014 Sep;29(5):239-51. doi: 10.1097/YIC.0000000000000031.

  PMID: 24583567 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

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Desvenlafaxine Succinate; Genotype

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids; Genetic Phenomena

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: January 14, 2009
• First Posted: January 16, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 10, 2011
• Results First Posted: November 25, 2010

Record last verified: 2011-03