Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Vs Placebo in Peri- and Postmenopausal Women - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00369343

Purpose

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.

Condition	Intervention	Phase
Depression Depressive Disorder Depressive Disorder, Major	Drug: Desvenlafaxine succinate sustained-release (DVS SR) Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Depression Diabetic Nerve Problems Fibromyalgia Menopause

Drug Information available for: Desvenlafaxine Succinic acid Desvenlafaxine Succinate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare DVS SR to placebo with respect to remission and response rates, anxiety scores, quality of life, safety, and tolerability. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2006
Study Completion Date:	July 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Desvenlafaxine succinate sustained-release (DVS SR) DVS-SR 50-200mg, QD, tablet form, treatment period up to 34 weeks
B: Placebo Comparator	Other: Placebo Placebo , QD, tablet form, treatment period up to 34 weeks

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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 MINI 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369343

Show 37 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3151A1-403
Study First Received:	August 25, 2006
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00369343 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Major Depressive Disorder
vasomotor symptoms
menopause
diabetic neuropathy
fibromyalgia

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Diabetic Neuropathies
Fibromyalgia
Myofascial Pain Syndromes
Psychotropic Drugs
Depressive Disorder, Major

Depressive Disorder
Behavioral Symptoms
Mental Disorders
O-desmethylvenlafaxine
Mood Disorders
Menopause
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder

Pharmacologic Actions
Behavioral Symptoms
Pathologic Processes
Mental Disorders
O-desmethylvenlafaxine
Therapeutic Uses
Mood Disorders
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on August 12, 2009