| April 25, 2008 |
| August 24, 2009 |
| April 2008 |
| September 2010 (final data collection date for primary outcome measure) |
| Safety: Descriptive statistics for AEs, vital sign measurements, Tanner Assessment scores, laboratory evaluations, and ECG data; Columbia Suicide-Severity Rating Scale data [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00669110 on ClinicalTrials.gov Archive Site |
| Efficacy: CDRS-R mean change from baseline; HAM-D17 mean change from baseline; CGI-S proportions of subjects in each category at each time point; CGI-I proportions of subjects in each category at each time point [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Study Evaluating DVS SR in the Treatment of Child and Adolescent Outpatients With Major Depressive Disorder |
| 6-Month, Multicenter, Open-Label, Flexible-Dose Study to Evaluate Safety, Efficacy, and Tolerability of Desvenlafaxine Succinate Sustained-Release Tablets in the Treatment of Child and Adolescent Outpatients With Major Depressive Disorder |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Single Group Assignment, Safety Study |
- Adolescence
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Pediatrics
|
| Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) |
| |
| |
| |
| Recruiting |
| 64 |
| September 2010 |
| September 2010 (final data collection date for primary outcome measure) |
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.
- All 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 Critiera:
- 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. |
| Both |
| 7 Years to 18 Years |
| No |
|
|
| United States |
| |
| NCT00669110 |
| Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| 3151A6-2001 |
| Wyeth |
|
| Study Director: |
Medical Monitor |
Wyeth |
|
|
| Wyeth |
| August 2009 |
