Phase 3
N=269
A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01371721 ↗Enrolled (actual)
269
Serious AEs
3.7%
Results posted
Feb 2017
Primary outcome: Primary: Percentage of Participants Experiencing a Treatment Emergent Adverse Event — 70.1; 75.3; 73.9; 73.1 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DVS SR (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing a Treatment Emergent Adverse Event |
70.1; 75.3; 73.9; 73.1 | — |
| SECONDARY Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases |
-5.55; -6.41; -5.32; -5.78 | — |
| SECONDARY Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases |
-0.78; -0.77; -0.82; -0.79 | — |
| SECONDARY Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26 |
90.9; 93.4; 92.9; 92.4 | — |
| SECONDARY Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases |
74.5; 78.7; 73.2; 75.6 | — |
| SECONDARY Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases |
63.6; 63.9; 57.1; 61.6; 27.3; 29.5 | — |
Summary
This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child and adolescent outpatients with major depressive disorder (MDD).
Eligibility Criteria
Inclusion Criteria
- Completed study B2061014 and who in the investigator's opinion would benefit from long term treatment with DVS SR
- Willingness and ability to comply with scheduled visits, treatment plan and procedures
Exclusion Criteria
- Subject requires precaution against suicide
- Subject not in a generally healthy condition
Data sourced from ClinicalTrials.gov (NCT01371721). 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.