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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressive Disorder, Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

Intervention Type DRUG

* tablet
* subjects randomly assigned to 10-200 mg/day by age group
* 6 month treatment period(\~182 days)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No