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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)

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226 United States
Contact
1-800-718-1021
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.
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- 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.
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- 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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