Back to resultsEvaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder (NAPA)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
SSR149415 - 100mg
SSR149415 - 250mg
Arm Description
Twice daily
Twice daily
Twice daily
Outcomes
Primary Outcome Measures
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
Secondary Outcome Measures
Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing
Number of patients with adverse events
Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores
Changes Clinical Global Impression (CGI) Severity and Improvement scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01606384
Brief Title
Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
Acronym
NAPA
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Twice daily
Arm Title
SSR149415 - 100mg
Arm Type
Experimental
Arm Description
Twice daily
Arm Title
SSR149415 - 250mg
Arm Type
Experimental
Arm Description
Twice daily
Intervention Type
Drug
Intervention Name(s)
VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Intervention Description
Pharmaceutical form: Capsule Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Capsule Route of administration: Oral
Primary Outcome Measure Information:
Title
Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing
Time Frame
4 weeks
Title
Number of patients with adverse events
Time Frame
Up to 6 weeks
Title
Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores
Time Frame
Baseline, 4 weeks
Title
Changes Clinical Global Impression (CGI) Severity and Improvement scores
Time Frame
Baseline, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23146246
Citation
Griebel G, Beeske 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.
Results Reference
derived
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Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder
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