A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD

Pfizer

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: DVS SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01371721

2008-002064-34 (EudraCT Number)

3151A6-3357 (Other Identifier)

B2061031

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: 269 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed study B2061014 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

• Subject requires precaution against suicide
• Subject not in a generally healthy condition

Trial design

269 participants in 1 patient group

Desvenlafaxine Succinate Sustained-Release

Experimental group

Treatment:

Drug: DVS SR