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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01432457
First received: September 9, 2011
Last updated: December 17, 2013
Last verified: December 2013
  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) at Week 8 [ Time Frame: Baseline to Week 8 (final on-therapy) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8 [ Time Frame: Baseline to Week 8 (final on-therapy) ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) [ Time Frame: Baseline to Week 8 (final on-therapy) ] [ Designated as safety issue: No ]
    CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.

  • Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S) [ Time Frame: Baseline to Week 8 (final on-therapy) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: Baseline to Week 8 (final on-therapy) ] [ Designated as safety issue: No ]
    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.

  • Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate [ Time Frame: Baseline to Week 8 (final on-therapy) ] [ Designated as safety issue: No ]
    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.

  • Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate [ Time Frame: Baseline to week 8 (final on-therapy) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score [ Time Frame: Baseline to Week 8 (final on-therapy) ] [ Designated as safety issue: Yes ]

    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.



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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432457

  Show 61 Study Locations
Sponsors 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
Results First Received: June 27, 2013
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
O-desmethylvenlafaxine
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014