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

• Conditions: Major Depressive Disorder

• Registration Number: EUCTR2004-002327-41-EE
• Lead Sponsor: Sanofi-Synthelabo Recherche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-07
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

- Male or female patients.
- 18 to 64 years of age.
- In patients or out patients.
- Written informed consent from the patient and/or legally authorized representative.
- Able to comply with the protocol and follow written and verbal instructions.
- Subjects of childbearing potential must have a confirmed negative serum beta-hCG prior to entry into Segment B and must employ an acceptable method of birth control at least on month prior to entry into Segment A, throughout the study, and at least one month after study completion.
- Diagnostic of major depressive disorder, as defined by DSMIV TR.
- Minimum total score of 22 on the MADRS.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
- The duration of the current depressive episode is greater than 2 years.
- Patients having a current score of >5 on the suicidal thoughts item of the MADRS (item10) and/or a score of 4 on the suicide item (item 3) of the Hamilton Depression Rating Scale at screening (V1, Day - 7) or baseline (V2, Day - 1) and/or endorses a Yes response (10 points) to items 4 (Have a suicide plan?) or 5 (Attempt suicide) of the C (suicidality) criteria of the MINI.
- History of a suicide attempt within 3 years prior to entry into Segment A.
- Patients whose current depressive episode is secondary to a general medical disorder (293.83).
- Patients with a history or presence or some other concomitant psychiatric disorders according to MINI criteria.
- Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months according to the MINI, except nicotine or caffeine dependence.
- Patients who have used the following prior to entry into Segment B : any antipsychotic within 3 months - fluoxetine within 35 days - any MAOI within 21 days - any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications as defined in (Section 9.9.2).
- Patients who test positive for any illicit drug included in the urine drug screen Visit 1 (Day - 7).
- A 20% or greater decrease in MADRS total score during Segment A or a MADRS total score of<22 at entry into Segment B.
- Females who are pregnant or breast-feeding.
- Severe or unstable cardiovascular, renal, hepatic, respiratory, hematological, endocrinological, neurological, or other somatic disease that, according to the Investigator's judgment, might interfere with the evaluation of study medication.
- ECG abnormalities of potential clinical significance including a QT interval with Bazett's correction (QTcB) > or equal to 500msec at entry into Segment B.
- Use of known inducers or potent inhibitors of CYP3A4 within 7 days of entry into Segment B. These medications should be discontinued at entry into Segment A. See (Appendix 1) for a list of CYP3A4 inhibitors and inducers. Note that phenobarbital should be washed out for at least 30 days prior to entry into Segment B.
- Use of drugs with known risk for Torsade de Pointes within 7 days of entry into Segment B. All medications listed (Appendix 2) should be discontinued at entry into Segment A and washed out for the full 7 days of Segment A.
- Patients not compliant in taking study medication during Segment A (e.g., takes less than 80% of the prescribed number of capsules).
- Patients with a positive HbsAg or anti-HCV antibody test at screening (V1, day - 7).
- Patients with any of the following at screening (V1, day - 7):
ALT > 2 times the upper limit of the normal range
AST >2 times the upper limit of the normal range
GGT >3 times the upper limit of the normal range
total or conjugated bilirubin above the upper limit of the normal range

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of a 100 mg fixed dose of saredutant compared to placebo in patients with major depressive disorder;Secondary Objective: To evaluate the tolerability and safety of saredutant in patients with major depressive disorder.<br>To evaluate the efficacy of saredutant compared to placebo on disability and quality of life in patients with major depressive disorder.<br>To evaluate plasma concentrations of saredutant and SR49596 and explore their relationships to efficacy and safety outcomes.<br>To evaluate the safety and tolerability of forty-four weeks of additional treatment with saredutant in patients completing the initial eight-week treatment period.;Primary end point(s): Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.