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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319709
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : March 12, 2009
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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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: SR58611A Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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)
Study Start Date : April 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00319709

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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
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Study Director: ICD CSD Sanofi

Additional Information:
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00319709     History of Changes
Other Study ID Numbers: EFC4846
EudraCT 2005-005597-67
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by Sanofi:
antidepressive agents
controlled clinical trial

Additional relevant MeSH terms:
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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