An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression (ZEPHIR)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Depressive Disorder

Treatments

Drug: SR58611A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00319709

EudraCT 2005-005597-67

EFC4846

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.

Enrollment

288 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Outpatients or inpatients
Major Depressive Disorder (MDD) with a recurrent Major Depressive Episode (MDE) according to DSM IV-TR criteria.
MADRS score equal of above 22.

Exclusion criteria

Patients with a current significant risk of suicide in the investigator's clinical judgment.
The duration of the current depressive episode is greater than 2 years.
Patients whose current depressive episode is secondary to a general medical condition
Patients with a lifetime history according to MINI at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
Patients with a current history according to MINI at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
Patients with severe or unstable concomitant medical conditions.
History of seizures other than a single childhood febrile seizure.
Patients with abnormal thyroid functioning.
Patients with clinically significant ECG findings at screening.
Patients who have taken an investigational drug in the last 3 months prior to screening.
Any subject who has previously participated in a SR58611A protocol.
Patients with Mini-Mental State Examination (MMSE) score < 25 at screening.