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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Desvenlafaxine Succinate

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.