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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: April 28, 2006
Last updated: March 10, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Depressive Disorder
Drug: SR58611A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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)

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 288
Study Start Date: April 2006
Study Completion Date: August 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00319709

Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Sanofi-Aventis Administrative Office
Belgrade, Serbia
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00319709     History of Changes
Other Study ID Numbers: EFC4846
EudraCT 2005-005597-67
Study First Received: April 28, 2006
Last Updated: March 10, 2009

Keywords provided by Sanofi:
antidepressive agents
controlled clinical trial

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 26, 2017