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An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression

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: NCT00256113
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE November 7, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date April 20, 2018
Study Start Date  ICMJE December 2004
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
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 NCT00256113 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
Official Title  ICMJE An Eight-Week, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety, and Tolerability of One Fixed 100 mg Dose of Saredutant in Patients With Major Depressive Disorder
Brief Summary

The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression.

The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression.

The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy of saredutant on disability and quality of life in patients with depression, and to evaluate blood levels of saredutant.

Detailed Description The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. Patients completing Segment B may be eligible for enrollment into Segment C, a 44-week, double blind extension. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.
Study Type  ICMJE Interventional
Study Phase  ICMJE 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: Saredutant succinate (SR48968C)
Study Arms  ICMJE 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: December 22, 2008)
467
Original Enrollment  ICMJE
 (submitted: November 17, 2005)
450
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Male or female patients.
  • 2. 18 to 64 years of age.
  • 3. Inpatients or outpatients.
  • 4. Written informed consent from the patient and/or legally authorized representative.
  • 5. Able to comply with the protocol and follow written and verbal instructions.
  • 6. Subjects of childbearing potential must have a confirmed negative serum b-hCG test prior to entry into Segment B and must employ an acceptable method of birth control (e.g., oral, depot, or implanted contraceptive method, IUDs, sterilization, barrier methods in conjunction with spermicide).
  • 7. Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent episode for at least one month prior to the entry.
  • 8. Minimum total score of 22 on the Montgomery-Asberg Depression Rating Scale (MADRS).

Exclusion Criteria:

  • 1. Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
  • 2. The duration of the current depressive episode is greater than 2 years.
  • 3. Patients who are currently suicidal or have a history of a suicide attempt within 3 years prior to entry.
  • 4. Patients whose current depressive episode is secondary to a general medical disorder.
  • 5. Patients with a history or presence of bipolar disorders or psychotic disorders according to the D and L criteria of the MINI.
  • 6. Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
  • 7. Patients with a history of failure to respond to treatment with paroxetine or other antidepressant medications.*
  • 8. Patients who have used the following prior to entry into Segment B: any antipsychotic within 3 months,-fluoxetine within 35 days, -any monoamine oxidase inhibitor within 21 days, any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications.
  • 9. Females who are pregnant or breast-feeding.
  • 10. Severe or unstable cardiovascular, renal, hepatic, respiratory, hematological, endocrinological, neurological, or other somatic disease that might interfere with the evaluation of study medication.
  • 11. History of seizures other than a single childhood febrile seizure.
  • 12. ECG abnormalities of potential clinical significance including a QT interval with Bazett's correction of 500 msec or more at entry.
  • 13. Use of known inducers or potent inhibitors of CYP3A4 within 7 days of entry.
  • 14. Use of drugs with known risk for Torsade de Pointes within 7 days of entry into Segment B.
  • 15. Participation in a clinical trial of an experimental therapy within 30 days prior to entry or prior participation in a clinical trial of saredutant.
  • 16. Patients with a positive HbsAg or anti-HCV antibody test at screening.
  • 17. Patients with any of the following at screening: ALT >2 times the upper limit of the normal range (XULN), AST >2XULN, GGT >3XULN, total or conjugated bilirubin >ULN
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Chile,   Croatia,   Czechia,   Estonia,   Germany,   Mexico,   Portugal
Removed Location Countries Czech Republic,   France
 
Administrative Information
NCT Number  ICMJE NCT00256113
Other Study ID Numbers  ICMJE EFC5575
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date April 2018

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