Phase 3
N=363
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01371734 ↗Enrolled (actual)
363
Serious AEs
1.4%
Results posted
Mar 2017
Primary outcome: Primary: Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) — -22.85; -23.70; -24.37 Score on a scale — p=0.587
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desvenlafaxine Succinate Sustained-Release (Drug); Placebo (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) |
-22.85; -23.70; -24.37 | 0.587 |
| SECONDARY Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106) |
-1.49; -1.51; -1.65 | 0.923 |
| SECONDARY Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 |
2.7; 0.9; 2.6; 6.2; 9.8; 12.2 | 0.729 |
| SECONDARY Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' |
8.85; 10.71; 14.78; 30.70; 32.17; 33.94 | 0.633 |
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).
Eligibility Criteria
Inclusion Criteria
- Age >=7 and 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
Data sourced from ClinicalTrials.gov (NCT01371734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.