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

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ClinicalTrials.gov Identifier: NCT01432457
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : January 20, 2014
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

September 9, 2011
September 13, 2011
June 27, 2013
January 20, 2014
January 20, 2014
October 2011
July 2012   (Final data collection date for primary outcome measure)
  • 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) ]
    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) ]
    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 [ Time Frame: Baseline to Week 8 ]
Complete list of historical versions of study NCT01432457 on ClinicalTrials.gov Archive Site
  • Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I) [ Time Frame: Baseline to Week 8 (final on-therapy) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]

    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.

  • Change From Baseline on the Clinical Global Impression Scale [ Time Frame: Baseline to Week 8 ]
  • Hamilton Rating Scale for Depression, 17-item response rate [ Time Frame: Baseline to Week 8 ]
  • Hamilton Rating Scale for Depression, 17-item remission rate [ Time Frame: Baseline to Week 8 ]
  • Change From Baseline on the Arizona Sexual Experiences Scale Total Score [ Time Frame: Baseline to Week 8 ]
Not Provided
Not Provided
 
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • 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
  • 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
  • Drug: placebo
    50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
  • Experimental: desvenlafaxine succinate sustained-release 50 mg/day
    Intervention: Drug: desvenlafaxine succinate sustained-release 50 mg/day
  • Experimental: desvenlafaxine succinate sustained-release 100 mg/day
    Intervention: Drug: desvenlafaxine succinate sustained-release 100 mg/day
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
924
900
August 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01432457
B2061028
3151A1-4420
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP