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

Depressive Disorder Clinical Trial

— ZEPHIR  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319709
• Other study ID #: EFC4846
• Secondary ID: EudraCT 2005-005
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2006
• Last updated: March 10, 2009
• Start date: April 2006
• Est. completion date: August 2007

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of HealthFinland: Finnish Medicines AgencySlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: August 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• SR58611A

Locations

Country	Name	City	State
Bulgaria	Sanofi-Aventis Administrative Office	Sofia
Finland	Sanofi-Aventis Administrative Office	Helsinki
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Serbia	Sanofi-Aventis Administrative Office	Belgrade
Slovakia	Sanofi-Aventis Administrative Office	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Bulgaria,  Finland,  Romania,  Serbia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

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