Clinical trial NCT00863798: Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-03-18
Enrollment: 682
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.

Primary outcomes:
measure: Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)
timeFrame: Baseline and Week 8 (or ET)
Secondary outcomes:
measure: Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)
timeFrame: Week 8 (or ET)
measure: Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)
timeFrame: Baseline and Week 8 (or ET )
measure: Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)
timeFrame: Baseline and Week 8 (or ET)
measure: Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)
timeFrame: Baseline and Week 8 (or ET )
measure: Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)
timeFrame: Week 8 (or ET)
measure: Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)
timeFrame: Week 8 (or ET)
measure: Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)
timeFrame: Week 8 (or ET)
measure: Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
timeFrame: Week 8 (or ET)
Other outcomes:
measure: Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations
timeFrame: Week 2, 4 and 8 (or ET)
measure: Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)
timeFrame: Baseline and Week 8 (or ET)
measure: Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)
timeFrame: Baseline and Week 8 (or ET)
measure: Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)
timeFrame: Week 8 (or ET)
measure: Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)
timeFrame: Week 8 (or ET)
measure: Discontinuation-Emergent Signs and Symptoms (DESS)
timeFrame: Week 8 to 10 (or ET)
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Encino
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Redlands
country: United States
facility: Pfizer Investigational Site
state: California
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Cromwell
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Maitland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: North Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Salem
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Media
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Herndon
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Midlothian
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Middleton
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Waukesha
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.