Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder - Full Text View

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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
Depressive Disorder, Major Depressive Disorder	Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: Depression

Drug Information available for: Desvenlafaxine Succinic acid Desvenlafaxine Succinate

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Extension study) up to Extension study Week 29 Follow up visit ] [ Designated as safety issue: Yes ]
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.
Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories [ Time Frame: Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study) ] [ Designated as safety issue: Yes ]
C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.

Enrollment:	40
Study Start Date:	May 2008
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) tablet subjects randomly assigned to 10-200 mg/day by age group 6 month treatment period(~182 days)

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.
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 Criteria:

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

Locations

United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, Florida
Pfizer Investigational Site
North Miami, Florida, United States, 33161
United States, Indiana
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67211
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70114
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Pfizer Investigational Site
Hershey, Pennsylvania, United States, 17033
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77008

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00669110 History of Changes
Other Study ID Numbers:	3151A6-2001, B2061013
Study First Received:	April 25, 2008
Results First Received:	April 21, 2011
Last Updated:	April 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

MDD
Depression
Pediatrics
Major Depressive Disorder

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012