Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432457
• Other study ID #: B2061028
• Secondary ID: 3151A1-4420
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2011
• Last updated: December 17, 2013
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 924
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• desvenlafaxine succinate sustained-release 50 mg/day
50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper
• desvenlafaxine succinate sustained-release 100 mg/day
100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day
• placebo
50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Pacific Clinical Research Medical Group	Arcadia	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Comprehensive NeuroScience, Incorporated	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	Pharmasite Research Inc	Baltimore	Maryland
United States	NorthCoast Clinical Trials Inc.	Beachwood	Ohio
United States	Southwestern Research, Incorporated	Beverly Hills	California
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio
United States	Neurobehavioral Research, Inc	Cedarhurst	New York
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	Carolina Clinical Research Services	Columbia	South Carolina
United States	Clinical Innovations, Inc.	Costa Mesa	California
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	KRK Medical Research	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Synergy Clinical Research of Escondido	Escondido	California
United States	Odyssey Research	Fargo	North Dakota
United States	Plains Medical Clinic	Fargo	North Dakota
United States	Prairie St. Johns Clinic - Fargo	Fargo	North Dakota
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Clinical Neuroscience Solutions Incorporated	Jacksonville	Florida
United States	Joliet Center for Clinical Research	Joliet	Illinois
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Accurate Clinical Trials, Inc.	Kissimmee	Florida
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Lincoln Research	Lincoln	Rhode Island
United States	Arkansas Psychiatric Clinic Clinical Research Trials, P.A.	Little Rock	Arkansas
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	CRI Worldwide, LLC	Marlton	New Jersey
United States	Suburban Research Associates	Media	Pennsylvania
United States	Radiant Research, Inc.	Murray	Utah
United States	AMR-Baber Research Inc.	Naperville	Illinois
United States	Synergy Clinical Research Center	National City	California
United States	Eastside Comprehensive Medical Center, LLC	New York	New York
United States	Medical and Behavioral Health Research Pc	New York	New York
United States	Heartland Pharma Development	North Platte	Nebraska
United States	American Medical Research, Inc.	Oak Brook	Illinois
United States	Pacific Research Partners	Oakland	California
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	Psychiatric Associates	Overland Park	Kansas
United States	Pasadena Research Institute, LLC	Pasadena	California
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	Dedicated Clinical Research	Phoenix	Arizona
United States	Deidcated Clinical Research	Phoenix	Arizona
United States	Oregon Center for Clinical Investigations, Inc.	Portland	Oregon
United States	Summit Research Network (Oregon), Inc.	Portland	Oregon
United States	Clinical Innovations, Inc.	Riverside	California
United States	Affiliated Research Institute	San Diego	California
United States	Clinical Innovations, Inc.	San Diego	California
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	California Neuroscience Research Medical Group, Inc	Sherman Oaks	California
United States	Carman Research	Smyrna	Georgia
United States	Midwest Research Group	St. Charles	Missouri
United States	Comprehensive NeuroScience, Inc.	St. Petersburg	Florida
United States	Viking Clinical Research Center	Temecula	California
United States	Collaborative Neuroscience Network, Inc. South Bay	Torrance	California
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Via Christi Research	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.	Baseline to Week 8 (final on-therapy)	No
Primary	Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline	Baseline to Week 8 (final on-therapy)	No
Secondary	Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)	CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.	Baseline to Week 8 (final on-therapy)	No
Secondary	Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.	Baseline to Week 8 (final on-therapy)	No
Secondary	Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.	Baseline to Week 8 (final on-therapy)	No
Secondary	Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as = 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.	Baseline to Week 8 (final on-therapy)	No
Secondary	Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of = 7.	Baseline to week 8 (final on-therapy)	No
Secondary	Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score	The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.; Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function.	Baseline to Week 8 (final on-therapy)	Yes

External Links

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