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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) | Clinical Trials | Clareo Health

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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

NCT01121484•Pfizer

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - 70 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (44)

Birmingham Psychiatry Pharmaceutical Studies, Inc.

Birmingham, Alabama, United States

Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

Little Rock, Arkansas, United States

Pacific Clinical Research Medical Group

Arcadia, California, United States

Southwestern Research, Inc.

Beverly Hills, California, United States

Catalina Research Institute LLC

Chino, California, United States

Pacific Clinical Research Medical Group

Orange, California, United States

Pacific Clinical Research Medical Group

Upland, California, United States

Western Affiliated Research Institute

Denver, Colorado, United States

Radiant Research, Inc.

Denver, Colorado, United States

Connecticut Clinical Research

Cromwell, Connecticut, United States

Key Dates

Start Date

June 1, 2010

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

April 4, 2012

Enrollment

439

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

desvenlafaxine succinate sustained-release

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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