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

Phase 3

Completed

Interventions: Drug: Desvenlafaxine Succinate Sustained-Release
Drug: Placebo

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).

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Experimental Arm 1 - high dose	Desvenlafaxine Succinate Sustained-Release	-
Experimental Arm 2 - low dose	Desvenlafaxine Succinate Sustained-Release	-
Placebo Arm	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)	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 Outcome Measures

Name	Time	Method
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)	Baseline and Week 8	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. Mean change from baseline was adjusted for the baseline total score, age group and gender.
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	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 equals (=) more affected.
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	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) or 2 (much improved) on the scale. Higher score = more affected.

Locations (42): Children's Hospital of Alabama Laboratory
🇺🇸
Birmingham, Alabama, United States
The University of Alabama at Birmingham, Office of Psychiatric Research
🇺🇸
Birmingham, Alabama, United States
Center for Advanced Improvement
🇺🇸
Tucson, Arizona, United States
Sun Valley Research Center
🇺🇸
Imperial, California, United States
MCB Clinical Research Centers
🇺🇸
Colorado Springs, Colorado, United States
Bliss Basement Pharmacy - Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Institute of Living/Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Institute of Living
🇺🇸
Hartford, Connecticut, United States
SJS Clinical Research, Inc.
🇺🇸
Destin, Florida, United States
Sarkis Clinical Trials
🇺🇸
Gainesville, Florida, United States
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Children's Hospital of Alabama Laboratory
🇺🇸Birmingham, Alabama, United States