Major Depressive Disorder
Conditions
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.
Interventions
DRUGVASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Pharmaceutical form: Capsule Route of administration: oral
DRUGPlacebo
Pharmaceutical form: Capsule Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events | Up to 6 weeks |
| Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores | Baseline, 4 weeks |
| Changes Clinical Global Impression (CGI) Severity and Improvement scores | Baseline, 4 weeks |
| Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing | 4 weeks |
Countries
United States
Outcome results
None listed