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: Placebo; Drug: Desvenlafaxine Succinate Sustained-Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT01371734

2008-001875-32 (EudraCT Number)

3151A6-3343 (Other Identifier)

B2061032

Details and patient eligibility

About

This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).

Enrollment: 363 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 behavior 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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363 participants in 3 patient groups, including a placebo group

Experimental Arm 1 - high dose

Experimental group

Treatment:

Drug: Desvenlafaxine Succinate Sustained-Release

Drug: Desvenlafaxine Succinate Sustained-Release

Experimental Arm 2 - low dose

Experimental group

Treatment:

Drug: Desvenlafaxine Succinate Sustained-Release

Drug: Desvenlafaxine Succinate Sustained-Release

Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo