Phase 2
Completed N=40
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
Depressive Disorder, Major Depressive Disorder
Source: ClinicalTrials.gov NCT00669110 ↗
Enrolled (actual)
40
Serious AEs
2.5%
Results posted
May 2011
Primary outcomePrimary: Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) — 13; 15; 1; 0 participants
Summary
The primary purpose of this study is to evaluate the long-term safety and tolerability of Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with major depressive disorder. A secondary aim is to evaluate the efficacy of DVS SR in the treatment of child and adolescent outpatients with major depressive disorder in an exploratory manner.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) |
13; 15; 1; 0 | — |
| PRIMARY Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories |
20; 20; 20; 20; 20; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatients who have completed 8-weeks of treatment in the preceding study, 3151A6-2000, and who, in the opinion of the investigator, would benefit from long-term treatment.
- Study participants who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article. Sexually active study participants must agree and commit to the use of condoms in addition to other contraceptive methods.
Exclusion Criteria
- Clinically important abnormalities on baseline physical examination or any clinically significant abnormality on electrocardiogram (ECG), laboratory test results, or vital signs recorded before the final study day (day 56 visit) of the preceding study 3151A6-2000.
- Unresolved clinically significant adverse events or serious adverse events in the preceding study 3151A6-2000.
- Poor compliance with the preceding study 3151A6-2000, as assessed by the investigator and the medical monitor.
- Other exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT00669110). 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.