A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety And Tolerability Of Desvenlafaxine Succinate Sustained-release (Dvs Sr) In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- Desvenlafaxine Succinate Sustained-Release
- Conditions
- Major Depressive Disorder
- Sponsor
- Pfizer
- Enrollment
- 363
- Locations
- 42
- Primary Endpoint
- Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Experimental Arm 1 - high dose
Intervention: Desvenlafaxine Succinate Sustained-Release
Experimental Arm 2 - low dose
Intervention: Desvenlafaxine Succinate Sustained-Release
Placebo Arm
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
Time Frame: Baseline and Week 8
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender.
Secondary Outcomes
- Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)(Baseline and Week 8)
- Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8(Weeks 1, 2, 3, 4, 6, and 8)
- Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'(Weeks 1, 2, 3, 4, 6, and 8)