Status:
COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Depressive Disorder, Major Depressive Disorder
Eligibility:
All Genders
7-18 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00669110
Start Date
May 1 2008
End Date
May 1 2010
Last Update
August 19 2021
Active Locations (9)
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1
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
2
Pfizer Investigational Site
North Miami, Florida, United States, 33161
3
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
4
Pfizer Investigational Site
Wichita, Kansas, United States, 67211