Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01432457
First received: September 9, 2011
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: desvenlafaxine succinate sustained-release 50 mg/day Drug: desvenlafaxine succinate sustained-release 100 mg/day Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline on the Clinical Global Impression Scale [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
- Hamilton Rating Scale for Depression, 17-item response rate [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
- Hamilton Rating Scale for Depression, 17-item remission rate [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
- Change From Baseline on the Arizona Sexual Experiences Scale Total Score [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: Yes ]
| Enrollment: | 924 |
| Study Start Date: | October 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: desvenlafaxine succinate sustained-release 50 mg/day |
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
Other Name: Pristiq
|
| Experimental: desvenlafaxine succinate sustained-release 100 mg/day |
Drug: 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 Comparator: Placebo |
Drug: placebo
50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432457
Show 61 Study Locations
Show 61 Study LocationsSponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01432457 History of Changes |
| Other Study ID Numbers: | B2061028, 3151A1-4420 |
| Study First Received: | September 9, 2011 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms O-desmethylvenlafaxine Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013