Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

This study is not yet open for participant recruitment.

Verified by Wyeth, January 2009

First Received: January 27, 2009 Last Updated: January 28, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00831415

Purpose

The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with MDD. The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Desvenlafaxine succinate sustained release	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Desvenlafaxine Succinic acid Desvenlafaxine Succinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 10-Month Open-Label Evaluation of The Long-Term Safety of Desvenlafaxine Succinate Sustained Release in Japanese Adults With Major Depressive Disorder

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety parameters: physical exam, laboratory assessments, ECGs, vital signs, adverse events. [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hamilton Psychiatric Rating Scale for Depression, [HAM-D17] score, Clinical Global Impression- Improvement [CGI-I] score [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	339
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DVS SR	Drug: Desvenlafaxine succinate sustained release

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatients who have completed double-blind therapy in short-term study for the indication of MDD, including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.

Exclusion Criteria:

Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831415

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

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:	3151A1-3350
Study First Received:	January 27, 2009
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00831415 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth:

Open-label Long-term Extension study

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
O-desmethylvenlafaxine
Mental Disorders
Psychotropic Drugs

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Antidepressive Agents
Behavioral Symptoms

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 May 06, 2009