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NCT01606384 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT01606384 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 100 participants.
The verdict
NCT01606384, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
Primary Objective: \- To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder. Secondary Objectives: * To evaluate the tolerability and safety of SSR149415 in patients with major depressive disorder. * To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients with major depressive disorder. * To evaluate plasma concentrations of SSR149415.
Interventions
- DRUG Placebo
- DRUG VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2006-12 |
| Est. Completion | 2007-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01606384
The ClinicalTrials.gov registry entry for NCT01606384 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01606384 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01606384 about?
NCT01606384 is a clinical study titled "Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder". Primary Objective: \- To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder. Secondary Objectives: * To evaluate the tolerability and safety of SSR149415 in patients with major...
What is the current status of trial NCT01606384?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2006-12. Estimated completion is 2007-08.
What interventions are being tested in trial NCT01606384?
The interventions under investigation include: Placebo (DRUG), VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415) (DRUG).
Who is sponsoring clinical trial NCT01606384?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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