Clinical trial NCT01432457: Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
Official title: A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 924
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: A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
* A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
* A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

Exclusion Criteria:

* Significant risk of suicide based on clinical judgment.
* 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.
* Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
* History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
* Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.

Primary outcomes:
measure: Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
timeFrame: Baseline to Week 8 (final on-therapy)
measure: Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
timeFrame: Baseline to Week 8 (final on-therapy)
Secondary outcomes:
measure: Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
timeFrame: Baseline to Week 8 (final on-therapy)
measure: Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
timeFrame: Baseline to Week 8 (final on-therapy)
measure: Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score
timeFrame: Baseline to Week 8 (final on-therapy)
measure: Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
timeFrame: Baseline to Week 8 (final on-therapy)
measure: Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
timeFrame: Baseline to week 8 (final on-therapy)
measure: Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score
timeFrame: Baseline to Week 8 (final on-therapy)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Deidcated Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
state: Arkansas
city: Arcadia
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Beverly Hills
country: United States
facility: Southwestern Research, Incorporated
state: California
city: Costa Mesa
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research of Escondido
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Pasadena
country: United States
facility: Pasadena Research Institute, LLC
state: California
city: Riverside
country: United States
facility: Clinical Innovations, Inc.
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: San Diego
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Center
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, Inc. South Bay
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Incorporated
state: Florida
city: Kissimmee
country: United States
facility: Accurate Clinical Trials, Inc.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: St. Petersburg
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Comprehensive NeuroScience, Incorporated
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Joliet
country: United States
facility: Joliet Center for Clinical Research
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: AMR-Baber Research Inc.
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Wichita
country: United States
facility: Via Christi Research
state: Kansas
city: Baltimore
country: United States
facility: Pharmasite Research Inc
state: Maryland
city: St. Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: North Platte
country: United States
facility: Heartland Pharma Development
state: Nebraska
city: Marlton
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center, LLC
state: New York
city: New York
country: United States
facility: Medical and Behavioral Health Research Pc
state: New York
city: Fargo
country: United States
facility: Prairie St. Johns Clinic - Fargo
state: North Dakota
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Fargo
country: United States
facility: Plains Medical Clinic
state: North Dakota
city: Beachwood
country: United States
facility: NorthCoast Clinical Trials Inc.
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Portland
country: United States
facility: Summit Research Network (Oregon), Inc.
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Columbia
country: United States
facility: Carolina Clinical Research Services
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Murray
country: United States
facility: Radiant Research, Inc.
state: Utah
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
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: 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: 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: Clayton AH, Tourian KA, Focht K, Hwang E, Cheng RF, Thase ME. Desvenlafaxine 50 and 100 mg/d versus placebo for the treatment of major depressive disorder: a phase 4, randomized controlled trial. J Clin Psychiatry. 2015 May;76(5):562-9. doi: 10.4088/JCP.13m08978.