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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.
ClinicalTrials.gov Identifier: NCT00319709
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE April 28, 2006
First Posted Date  ICMJE April 27, 2006
Last Update Posted Date March 12, 2009
Study Start Date  ICMJE April 2006
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2006)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00319709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2006)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder
Intervention  ICMJE Drug: SR58611A
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2008)
288
Original Enrollment  ICMJE
 (submitted: April 28, 2006)
280
Actual Study Completion Date August 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Finland,   Romania,   Serbia,   Slovakia
Removed Location Countries Former Serbia and Montenegro,   Poland
 
Administrative Information
NCT Number  ICMJE NCT00319709
Other Study ID Numbers  ICMJE EFC4846
EudraCT 2005-005597-67
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP