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. Identifier: NCT00250614
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : June 9, 2010
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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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: Saredutant succinate (SR48968C) Phase 3

Detailed Description:
The study is a multicenter, US, 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 telephone visit and a post-study office visit 3 days and 1 week, respectively, after intake of the last dose of study medication.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : April 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00250614

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Study Director: Lisa ARVANITIS, MD Sanofi

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00250614     History of Changes
Other Study ID Numbers: EFC5572
Saredutant (SR48968C)
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010

Keywords provided by Sanofi:
antidepressive agents
controlled clinical trial

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms