A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

Pfizer

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: DVS SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01371708

2008-001876-67 (EudraCT Number)

B2061030

3151A6-3344 (Other Identifier)

Details and patient eligibility

About

This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD).

Enrollment: 283 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR
• Willingness and ability to comply with scheduled visits, treatment plan, and procedures

Exclusion criteria

• Requires precaution against suicide
• Not in generally healthy medical condition
• Poor compliance with study drug or study procedures during participation in study B2061032

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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283 participants in 1 patient group

Desvenlafaxine Succinate Sustained-Release

Experimental group

Treatment:

Drug: DVS SR