A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
|ClinicalTrials.gov Identifier: NCT01372150|
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : November 20, 2015
Last Update Posted : May 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: desvenlafaxine succinate sustained release Drug: fluoxetine Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||November 2011|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
|Experimental: DVS SR||
Drug: desvenlafaxine succinate sustained release
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.
Active control for assay sensitivity
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
- Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score [ 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. Adjusted mean presented.
- Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score [ Time Frame: 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. Adjusted mean presented.
- Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 [ Time Frame: Baseline and 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.
- Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372150
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|