A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

Pfizer

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: fluoxetine; Drug: desvenlafaxine succinate sustained release; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01372150

B2061014

2008-002063-13 (EudraCT Number)

3151A6-3356 (Other Identifier)

Details and patient eligibility

About

This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).

Enrollment: 340 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >=7 and <18 years of age
• Primary diagnosis of major depressive disorder (MDD)
• CDRS-R score >40

Exclusion criteria

• History of suicidal behaviour, or requires precaution against suicide
• Not in generally healthy medical condition
• History of psychosis or bipolar disorder
• Seizure disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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340 participants in 3 patient groups

DVS SR

Experimental group

Treatment:

Drug: desvenlafaxine succinate sustained release

Fluoxetine

Other group

Description:

Active control for assay sensitivity

Treatment:

Drug: fluoxetine

Placebo

Experimental group

Treatment:

Drug: placebo