Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
NCT00619619 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2011-02-23
Summary
The primary purpose of this study is to test the safety and tolerability of single ascending doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent outpatients with major depressive disorder. This study will also characterize the pharmacokinetic profile of DVS SR in children and adolescents with major depressive disorder.
Conditions
Interventions
- DRUG
-
Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks.
Sponsors & Collaborators
-
Wyeth is now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 7 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2009-11-30
- Completion
- 2009-11-30
Countries
- United States
Study Locations
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