Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00669110
First received: April 25, 2008
Last updated: April 21, 2011
Last verified: April 2011

April 25, 2008
April 21, 2011
May 2008
May 2010   (final data collection date for primary outcome measure)
  • Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline (Extension study) up to Extension study Week 29 Follow up visit ] [ Designated as safety issue: Yes ]
    AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.
  • Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories [ Time Frame: Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study) ] [ Designated as safety issue: Yes ]
    C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.
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 ]
Complete list of historical versions of study NCT00669110 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depressive Disorder, Major Depressive Disorder
Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
  • tablet
  • subjects randomly assigned to 10-200 mg/day by age group
  • 6 month treatment period(~182 days)
Experimental: A
Intervention: Drug: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2010
May 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.
  • 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.
Both
7 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00669110
3151A6-2001, B2061013
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP