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

An Eight-Week, Double-Blind Placebo Controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Elderly Patients With Major Depressive Disorder (MDD)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00319709

Acronym

ZEPHIR

Enrollment

288

Registered

2006-04-27

Start date

2006-04-30

Completion date

2007-08-31

Last updated

2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Keywords

depression, antidepressive agents, controlled clinical trial

Brief summary

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.

Interventions

DRUGSR58611A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.	—

Secondary

Measure	Time frame
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.	—

Countries

Bulgaria, Finland, Romania, Serbia, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026