Phase 3 N=340 Randomized Triple-blind Treatment

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

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01372150 ↗

Enrolled (actual)

340

Serious AEs

1.2%

Results posted

Nov 2015

Primary outcome: Primary: Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score — -23.07; -24.79; -22.61 Score on a Scale — p=0.226

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: desvenlafaxine succinate sustained release (Drug); fluoxetine (Drug); placebo (Drug)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 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	-23.07; -24.79; -22.61	0.226
SECONDARY Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score	-1.71; -1.88; -1.70	0.224
SECONDARY Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8	1.0; 3.0; 2.7; 7.8; 11.9; 6.3	0.924
SECONDARY Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'	8.82; 14.85; 9.01; 29.13; 33.33; 35.45	0.186

Summary

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).

Eligibility Criteria

Inclusion Criteria

Age >=7 and 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01372150). 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.