Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00406640

Purpose

Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are postmenopausal.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Desvenlafaxine Succinic acid Escitalopram Escitalopram oxalate Desvenlafaxine Succinate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To assess efficacy measured by the change from baseline on the Hamilton Rating Scale for Depression total score over 8 weeks of treatment with DVS SR compared to treatment with escitalopram in postmenopausal women with MDD. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare DVS SR to escitalopram 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:	500
Study Start Date:	December 2006
Study Completion Date:	October 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Desvenlafaxine succinate sustained-release (DVS SR) flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.
B: Active Comparator	Drug: Escitalopram Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.

Eligibility

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

Criteria

Inclusion Criteria:

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: NCT00406640

Show 71 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Argentina: Scheima@wyeth.com
Principal Investigator:	Trial Manager	For Chile: scheima@wyeth.com
Principal Investigator:	Trial Manager	For Mexico: gomezzlj@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3151A1-402
Study First Received:	November 29, 2006
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00406640 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

MDD
Major Depressive Disorder
Depression

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Pathologic Processes
O-desmethylvenlafaxine
Mental Disorders
Therapeutic Uses

Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
Disease
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009