Phase 3
Completed 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
Source: ClinicalTrials.gov NCT01371721 ↗Enrolled (actual)
269
Serious AEs
3.7%
Results posted
Feb 2017
Primary outcomePrimary: Percentage of Participants Experiencing a Treatment Emergent Adverse Event — 70.1; 75.3; 73.9; 73.1 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 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 | — |
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) 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.