NCT00669110

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder, Major Depressive Disorder

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-04-29
• Last updated: 2021-08-19
• Results posted: 2011-05-16

Locations

9 sites across 1 country: United States