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Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder (NAPA)

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: May 23, 2012
Last updated: May 24, 2012
Last verified: May 2012

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.

Condition Intervention Phase
Major Depressive Disorder
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study Evaluating the Pharmacodynamic Effects of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) on Hypothalamic-pituitary-adrenal Axis Function in Outpatients With Major Depressive Disorder

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing [ Time Frame: 4 weeks ]
  • Number of patients with adverse events [ Time Frame: Up to 6 weeks ]
  • Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores [ Time Frame: Baseline, 4 weeks ]
  • Changes Clinical Global Impression (CGI) Severity and Improvement scores [ Time Frame: Baseline, 4 weeks ]

Enrollment: 100
Study Start Date: December 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Twice daily
Drug: Placebo
Pharmaceutical form: Capsule Route of administration: Oral
Experimental: SSR149415 - 100mg
Twice daily
Pharmaceutical form: Capsule Route of administration: oral
Experimental: SSR149415 - 250mg
Twice daily
Pharmaceutical form: Capsule Route of administration: oral

Detailed Description:

The study consisted of three segments (A, B and C). Segment A was a 1 to 4-week, drug-free, screening and baseline period. Segment B was a 4-week, double-blind period. After the last dose of double-blind study medication in Segment B, all patients had to enter Segment C, a 1-week drug-free, follow-up period.

The total study duration for one patient participating in all segments of the study was 6 weeks.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria :

  • Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) and the Mini International Neuropsychiatric Interview (MINI) criteria.

Exclusion criteria:

  • Outpatients unwilling to be hospitalized a total of 6 nights and 8 days.
  • Total score of less than 21 (<21) on the 17-item Hamilton Depression Rating Scale (HAM-D) at Visit 1 (Day -7) or Visit 5 (Day -1).
  • Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset or is secondary to a general medical disorder.
  • Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months according to the MINI, except nicotine or caffeine dependence.
  • Patients who have used the following prior to entry into Segment B: any antipsychotic within 3 months; fluoxetine within 1 month; any monoamine oxidase inhibitor (MAOI) within 2 weeks; any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Please refer to this study by its identifier: NCT01606384

United States, New Jersey
Bridgewater, New Jersey, United States
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT01606384     History of Changes
Other Study ID Numbers: PDY5467
Study First Received: May 23, 2012
Last Updated: May 24, 2012

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Arginine Vasopressin
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs processed this record on May 25, 2017