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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
363
Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.
Subjects randomized to the Placebo treatment arm will receive placebo tablets
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
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.
Time frame: Baseline and Week 8
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)
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.
Time frame: 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 equals (=) more affected.
Time frame: 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) or 2 (much improved) on the scale. Higher score = more affected.
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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
...and 32 more locations
Time frame: Weeks 1, 2, 3, 4, 6, and 8