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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.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01606384
First received: May 23, 2012
Last updated: May 24, 2012
Last verified: May 2012

May 23, 2012
May 24, 2012
December 2006
August 2007   (final data collection date for primary outcome measure)
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01606384 on ClinicalTrials.gov Archive Site
  • Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
  • Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • Changes Clinical Global Impression (CGI) Severity and Improvement scores [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
    Pharmaceutical form: Capsule Route of administration: oral
  • Drug: Placebo
    Pharmaceutical form: Capsule Route of administration: Oral
  • Placebo Comparator: Placebo
    Twice daily
    Intervention: Drug: Placebo
  • Experimental: SSR149415 - 100mg
    Twice daily
    Intervention: Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
  • Experimental: SSR149415 - 250mg
    Twice daily
    Intervention: Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Griebel G, Beeské S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2007
August 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01606384
PDY5467
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP