Study Evaluating DVS SR in the Treatment of Child and Adolescent Outpatients With Major Depressive Disorder - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00669110

Purpose

The primary purpose of this study is to evaluate the long-term safety and tolerability of Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with major depressive disorder. A secondary aim is to evaluate the efficacy of DVS SR in the treatment of child and adolescent outpatients with major depressive disorder in an exploratory manner.

Condition	Intervention	Phase
Adolescence Depression Depressive Disorder Depressive Disorder, Major Pediatrics	Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	6-Month, Multicenter, Open-Label, Flexible-Dose Study to Evaluate Safety, Efficacy, and Tolerability of Desvenlafaxine Succinate Sustained-Release Tablets in the Treatment of Child and Adolescent Outpatients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Children's Health Depression

Drug Information available for: Desvenlafaxine Succinic acid Desvenlafaxine Succinate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety: Descriptive statistics for AEs, vital sign measurements, Tanner Assessment scores, laboratory evaluations, and ECG data; Columbia Suicide-Severity Rating Scale data [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy: CDRS-R mean change from baseline; HAM-D17 mean change from baseline; CGI-S proportions of subjects in each category at each time point; CGI-I proportions of subjects in each category at each time point [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

Eligibility

Ages Eligible for Study:	7 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatients who have completed 8-weeks of treatment in the preceding study, 3151A6‑2000, and who, in the opinion of the investigator, would benefit from long‑term treatment.
All study participants who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article. Sexually active study participants must agree and commit to the use of condoms in addition to other contraceptive methods.

Exclusion Critiera:

Clinically important abnormalities on baseline physical examination or any clinically significant abnormality on electrocardiogram (ECG), laboratory test results, or vital signs recorded before the final study day (day 56 visit) of the preceding study 3151A6-2000.
Unresolved clinically significant adverse events or serious adverse events in the preceding study 3151A6-2000.
Poor compliance with the preceding study 3151A6-2000, as assessed by the investigator and the medical monitor.

Other exclusion criteria apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669110

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, Arkansas
	Recruiting
Little Rock, Arkansas, United States, 72205
United States, Florida
	Withdrawn
North Miami, Florida, United States, 33161
United States, Indiana
	Recruiting
Terre Haute, Indiana, United States, 47802
United States, Kansas
	Recruiting
Wichita, Kansas, United States, 67211
United States, Louisiana
	Withdrawn
New Orleans, Louisiana, United States, 70114
United States, New York
	Not yet recruiting
New York, New York, United States, 10032
United States, Ohio
	Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
	Recruiting
Hershey, Pennsylvania, United States, 17033
United States, Texas
	Recruiting
Houston, Texas, United States, 77008

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:	3151A6-2001
Study First Received:	April 25, 2008
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00669110 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

MDD
Depression
Pediatrics
Major Depressive Disorder

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 November 05, 2009