Change from baseline in Hamilton Depression Rating scale (HAM-D) total score
8 weeks
The primary outcome measure is the time to relapse of depressive symptoms (in days) during the double-blind study phase.
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
17-item Hamilton Depression Rating Scale (HAM-D) total score
14-item Hamilton Anxiety Rating Scale (HAM-A) total score
Secondary Endpoints
Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score
8 weeks
Change in Clinical Global Impression Severity score. Change in MADRS total score. Change in HAM-A total score
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.
Inclusion Criteria:
* Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score =\> 30
Exclusion Criteria:
* Patient is at immediate risk for suicidal behavior
* Patient wit...
SR58611A is an investigational small molecule being developed for psychiatric conditions, specifically generalized anxiety disorder, depressive disorder, and major depressive disorder. It has been studied in Phase 3 clinical trials for these indications, though it is not approved and remains in clinical development.
Who makes SR58611A?
SR58611A is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi has sponsored multiple Phase 3 clinical trials evaluating the drug for anxiety and depressive disorders.
What phase is SR58611A in?
SR58611A is in Phase 3 clinical development. It has completed three Phase 3 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities for any indication.
What clinical trials is SR58611A in?
SR58611A has completed three Phase 3 trials: NCT00266747 and NCT00332891 for generalized anxiety disorder, NCT00319709 for depression in elderly patients, and NCT00345098 for prevention of depression relapse in major depressive disorder. These trials enrolled a total of 1,454 participants.
Is SR58611A the same as another drug?
SR58611A is the primary name used in clinical trial records for this investigational compound. No alternative names have been associated with it in the available trial information, so it is not known to be the same as any other marketed drug.