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Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)

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NCT01121484

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and
spoken English.

- Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less
than 12 consecutive months with at least 6 consecutive months of spontaneous
amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or
6 months postsurgical bilateral oophorectomy (with or without hysterectomy).
Perimenopausal women defined by the presence of any of the following within 6 months
before baseline:

1. an absolute change of 7 days or more in menstrual cycle length within 6 months
before baseline;

2. a change in menstrual flow amount (2 or more flow categories, eg, from light or
moderately light to moderately heavy or heavy);

3. a change in duration (absolute change of 2 or more days); or

4. periods of amenorrhea lasting at least 3 months.

- A primary diagnosis of major depressive disorder (MDD) based on the criteria in the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision
(DSM-IV-TR), single or recurrent episode, without psychotic features using the
modified Mini International Neuropsychiatric Interview (MINI).

- A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the
screening and baseline (day -1) visits and no more than a 5-point improvement from
screening to baseline.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie,
Effexor® or Effexor XR®, 1 year prior to baseline.

- Treatment-resistant; eg, in the past 3 years if any of the following treatments have
failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant
medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy
(eg, behavior therapy, behavior-marital therapy).

- 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.

- Known presence of raised intraocular pressure or history of narrow-angle glaucoma.

NCT01121484
Pfizer
Completed
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)

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Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder
A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women 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 DVS SR tablets taken orally once daily.
    Other Name: Pristiq
  • Drug: placebo
    Placebo tablets taken orally once daily.
  • Experimental: desvenlafaxine succinate sustained-release
    Intervention: Drug: desvenlafaxine succinate sustained-release
  • 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
439
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English.

  • Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline:

    1. an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
    2. a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
    3. a change in duration (absolute change of 2 or more days); or
    4. periods of amenorrhea lasting at least 3 months.
  • A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI).
  • A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline.

Exclusion Criteria:

  • Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.
  • Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).
  • 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.
  • Known presence of raised intraocular pressure or history of narrow-angle glaucoma.
Sexes Eligible for Study: Female
40 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01121484
3151A1-3364
B2061029
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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