Phase 3
Completed 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
Source: ClinicalTrials.gov NCT01371708 ↗Enrolled (actual)
283
Serious AEs
4.6%
Results posted
Dec 2016
Primary outcomePrimary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) — 78.0; 73.1; 71.1 Percentage of participants
◆ Published Evidence
Emerging
7citations · ~1 / year
Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials.
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).
Linked Publications
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Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.