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

Study Overview
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Brief Summary
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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).

Official Title
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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLUOXETINE-REFERENCED, 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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: desvenlafaxine succinate sustained release
* Drug: fluoxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DVS SR<br> | Drug: desvenlafaxine succinate sustained release<br>* Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.<br>|
| Other: Fluoxetine<br>Active control for assay sensitivity | Drug: fluoxetine<br>* Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules<br>|
| Experimental: Placebo<br> | Drug: placebo<br>* Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score | 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. Adjusted mean presented. | Baseline and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score | A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented. | Baseline and Week 8 | 
| Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Baseline and 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' | A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Weeks 1, 2, 3, 4, 6, and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major depressive disorder, MDD, depression