a fifty-two-week study to evaluate the safety of saredutant in adult and elderly patients with depression

Conditions: Depressive Disorder

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 tolerability of a 100 mg dose of saredutant in adult and elderly patients with depression. the secondary objective is to evaluate blood levels of saredutant.

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. all treated 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.

Eligibility criteria:
inclusion criteria: * 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 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 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.

Keywords: depression antidepressive agents clinical trial