Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00369343
First received: August 25, 2006
Last updated: April 9, 2012
Last verified: April 2012

August 25, 2006
April 9, 2012
September 2006
November 2007   (final data collection date for primary outcome measure)
Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17
To demonstrate efficacy compared with placebo, measured by the change from baseline on the 17-item, Hamilton Rating Scale for Depression (HAM-D17) total score over 8 weeks of treatment with DVS SR or placebo in peri- and postmenopausal subjects with MDD
Complete list of historical versions of study NCT00369343 on ClinicalTrials.gov Archive Site
  • Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
  • Percentage of Patients Achieving Remission [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
  • Percentage of Patients Achieving Response to Treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
  • Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.
  • Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
  • Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months [ Time Frame: open label baseline and 6 months ] [ Designated as safety issue: No ]
    HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.
  • Clinical Global Impression Improvement (CGI-I) Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)
  • Percentage of Patients Achieving Remission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.
  • Percentage of Patients Achieving a Response to Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
  • Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months [ Time Frame: open label baseline to 6 months ] [ Designated as safety issue: No ]
    The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.
  • Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months [ Time Frame: open label baseline to 6 months ] [ Designated as safety issue: No ]
    EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
  • Discontinuation-Emergent Signs and Symptoms (DESS) Total Score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of "new symptoms" and "old (but worse) symptoms" (1) and 0 for "old and unchanged symptom," "absent," or "old symptom but improved" for a total possible range of 0 to 43. A higher score indicates more symptoms.
To compare DVS SR to placebo with respect to remission and response rates, anxiety scores, quality of life, safety, and tolerability.
Not Provided
Not Provided
 
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder

Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Depression
  • Depressive Disorder
  • Depressive Disorder, Major
  • Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
    DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
  • Drug: Placebo
    Placebo, daily (QD), tablet form, treatment period up to 8 weeks
  • Experimental: A
    Intervention: Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Kornstein SG, Jiang Q, Reddy S, Musgnung JJ, Guico-Pabia CJ. Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2010 Aug;71(8):1088-96.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
381
July 2008
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive.
  • A primary diagnosis of MDD, single or recurrent episode, without psychotic features using the modified International Neuropsychiatric Interview (MINI).
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the screening and baseline visit.

Exclusion Criteria:

  • Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline.
  • Current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
  • A history or active presence of clinically important medical disease.

Additional criteria apply.

Female
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00369343
3151A1-403
No
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2012

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