An Eight-Week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Major Depressive Disorder

Sanofi

Status and phase

Completed

Phase 2

Conditions

Depressive Disorder

Treatments

Drug: SSR149415

Study type

Interventional

Funder types

Industry

Identifiers

NCT00358631

DFI5878

Details and patient eligibility

About

The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and escitalopram 10 mg once daily in outpatients with major depressive disorder.

Enrollment

319 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of major depressive disorder, as defined by DSM-IV criteria and confirmed by the semi-structured MINI, recurrent episode.

Exclusion criteria

Total score of less than 24 on the MADRS.
HAM-D total score less than 18.
Duration of the current depressive episode less than 1 month or greater than 2 years.
Patients with a history or presence of bipolar disorders or psychotic disorders.
Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, MAOIs within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week except as allowed in the protocol.

The investigator will evaluate whether there are other reasons why a patient may not participate