Status:
COMPLETED
A Fifty-two-week Study to Evaluate the Safety of Saredutant in Adult and Elderly Patients With Depression
Lead Sponsor:
Sanofi
Conditions:
Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the long-term safety of saredutant (or SR48968C) in adult and elderly patients with depression.The primary objective is to evaluate the long-term safety and tol...
Detailed Description
The study is a multicenter, US, open-label study consisting of two segments (A and B). Segment A is a minimum 1-week (maximum 4-week) screening period and Segment B is a 52-week, open-label period. Al...
Eligibility Criteria
Inclusion
- Male or female patients.
- At least 18 years of age.
- Inpatients or outpatients.
- 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 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).
- 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.
- Minimum total score of 18 on the Hamilton Depression Rating Scale (HAM-D).
Exclusion
- 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 who are currently suicidal or have a history of a suicide attempt within 3 years prior to entry.
- Patients whose current depressive episode is secondary to a general medical disorder.
- Patients with a history or presence of bipolar disorders or psychotic disorders according to the D and L criteria of the MINI.
- Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
- Patients with a history of failure to respond to treatment with paroxetine or other antidepressant medications.
- Patients who have used the following prior to entry into Segment B: fluoxetine within 28 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.
- Females who are pregnant or breast-feeding.
- Severe or unstable cardiovascular, renal, hepatic, respiratory, hematological, endocrinological, neurological, or other somatic disease that might interfere with the evaluation of study medication.
- History of seizures other than a single childhood febrile seizure.
- ECG abnormalities of potential clinical significance including a QT interval with Bazett's correction of 500 msec or more at entry.
- Use of known inducers or potent inhibitors of CYP3A4 within 7 days of entry.
- Use of drugs with known risk for Torsade de Pointes within 7 days of entry into Segment B.
- Participation in a clinical trial of an experimental therapy within 30 days prior to entry or prior participation in a clinical trial of saredutant.
- Patients with a positive HbsAg or anti-HCV antibody test at screening.
- 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
- Elderly patients with a Mini-Mental State Examination total of score of \<25.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT00250653
Start Date
May 1 2005
End Date
April 1 2007
Last Update
February 17 2012
Active Locations (1)
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1
Administrative Office
Bridgewater, New Jersey, United States, 08807