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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: Completed Phase 2 study, sponsored by Sanofi.

NCT01606384 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 100 participants
Start Date 2006-12
Est. Completion 2007-08
Phase Phase 2
Sanofi

713 total trials

What the finished NCT01606384 record still lists

NCT01606384 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01606384 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01606384's enrollment target sits among peer trials

100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01606384, the US trial registry maintained by the National Library of Medicine. NCT01606384 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.