Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00250653 |
The purpose of the study is to evaluate the long-term safety of saredutant (or SR48968C) in adult and elderly patients with depression.The primary objective is to evaluate the long-term safety and tolerability of a 100 mg dose of saredutant in adult and elderly patients with depression. The secondary objective is to evaluate blood levels of saredutant.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder |
Drug: Saredutant succinate (SR48968C) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Fifty-Two-Week, Multicenter, Open-Label Study Evaluating the Long-Term Safety and Tolerability of Saredutant in Adult and Elderly Patients With Major Depressive Disorder |
Estimated Enrollment: | 360 |
Study Start Date: | May 2005 |
The study is a multicenter, US, open-label study consisting of two segments (A and B). Segment A is a minimum
1-week (maximum 4-week) screening period and Segment B is a 52-week, open-label period. All treated patients must complete a post-study telephone visit and a post-study office visit 3 days and 1 week, respectively, after intake of the last dose of study medication.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | LTS5577, Saredutant (SR48968C) |
Study First Received: | November 7, 2005 |
Last Updated: | June 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00250653 History of Changes |
Health Authority: | United States: Food and Drug Administration |
depression antidepressive agents clinical trial |
Depression Mental Disorders Mood Disorders Depressive Disorder, Major |
Depressive Disorder Antidepressive Agents Behavioral Symptoms |
Pathologic Processes Disease Depression Mental Disorders |
Mood Disorders Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |