Depressive Disorder
Conditions
Keywords
depression, antidepressive agents, clinical trial
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 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.
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. 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.
Interventions
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the proportion of patients experiencing at least one treatment-emergent adverse event. | — |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary outcomes are incidences of potentially clinically significant abnormalities and the changes from baseline in the values for clinical laboratories, vital signs, and electrocardiogram parameters. | — |
Countries
United States
Outcome results
None listed