NCT00250653已完成3 期
A Fifty-two-week, Multicenter, Open-label Study Evaluating the Long-term Safety and Tolerability of Saredutant in Adult and Elderly Patients With Major Depressive Disorder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 365
- 试验地点
- 2
- 主要终点
- The primary outcome is the proportion of patients experiencing at least one treatment-emergent adverse event.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
The primary outcome is the proportion of patients experiencing at least one treatment-emergent adverse event.
次要结局
- 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.
研究者
研究点 (2)
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