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

Wyeth

Status and phase

Completed

Phase 2

Conditions

Depressive Disorder, Major Depressive Disorder

Treatments

Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00669110

3151A6-2001

B2061013

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

7 to 18 years old

Volunteers

No Healthy Volunteers

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.