Phase 3
N=283
A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01371708 ↗Enrolled (actual)
283
Serious AEs
4.6%
Results posted
Dec 2016
Primary outcome: Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) — 78.0; 73.1; 71.1 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
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) |
78.0; 73.1; 71.1 | — |
| PRIMARY Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) |
74.0 | — |
| SECONDARY Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases |
-6.79; -10.72; -8.57 | — |
| SECONDARY Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group) |
-8.63 | — |
| SECONDARY Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases |
-1.02; -1.44; -0.70 | — |
| SECONDARY Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group) |
-1.05 | — |
| SECONDARY Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases |
87.3; 94.7; 89.3 | — |
| SECONDARY Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group) |
90.3 | — |
| SECONDARY Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases |
54.0; 73.7; 53.6; 33.3; 21.1; 35.7 | — |
| SECONDARY Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group) |
60.2; 30.1; 8.5; 0.6; 0.6; 0.0 | — |
| SECONDARY Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases |
73.0; 89.5; 75.0 | — |
| SECONDARY Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group) |
79.0 | — |
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 B2061032 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
- Requires precaution against suicide
- Not in generally healthy medical condition
- Poor compliance with study drug or study procedures during participation in study B2061032
Data sourced from ClinicalTrials.gov (NCT01371708). 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.