Clinical trial NCT00798707: Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of 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 (25 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: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 709
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 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.


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 judgement, 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 the 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) Total Score
timeFrame: Week 8 to 10 (or ET)
Locations:
city: Arcadia
country: United States
facility: Pfizer Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Cerritos
country: United States
facility: Pfizer Investigational Site
state: California
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Alamitos
country: United States
facility: Pfizer Investigational Site
state: California
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Smyrna
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Libertyville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: East Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Brown Deer
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Toyoake
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Noda
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Kitakyusyu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Shirakawa
country: Japan
facility: Pfizer Investigational Site
state: Fukushima
city: Fujioka
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Kumagaya
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Hatsukaichi
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Kure
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Pfizer Investigational Site
state: Ishikawa
city: Minamiashigara
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yatsushiro
country: Japan
facility: Pfizer Investigational Site
state: Kumamoto
city: Matsumoto
country: Japan
facility: Pfizer Investigational Site
state: Nagano
city: Sakai
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kanzaka
country: Japan
facility: Pfizer Investigational Site
state: Saga
city: Misato
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kusatsu
country: Japan
facility: Pfizer Investigational Site
state: Shiga
city: Bunkyo
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiyoda
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiyoda
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Itabashi
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Katsushika
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Kodaira
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nakano
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shibuya
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shibuya
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjyuku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Suginami
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Taito
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toshima
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Meguro
country: Japan
facility: Pfizer Investigational Site
state: Toyko
city: Ube
country: Japan
facility: Pfizer Investigational Site
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukushima
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Saitama
country: Japan
facility: Pfizer Investigational Site
city: Saitama
country: Japan
facility: Pfizer Investigational Site
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: Iwata N, Tourian KA, Hwang E, Mele L, Vialet C. Efficacy and safety of desvenlafaxine 25 and 5050% shaded blockmg/day in a randomized, placebo-controlled study of depressed outpatients. J Psychiatr Pract. 2013 Jan;19(1):5-14. doi: 10.1097/01.pra.0000426323.59698.64.