EUCTR2005-004006-81-SK进行中（未招募）1 期
A double-blind, 6 to 12-month, multicenter, multinational, randomized study evaluating the efficacy and safety of SR58611A (350 mg q12) versus placebo in the prevention of relapse / recurrence of depressive symptoms in patients with major depressive disorder improved after 8 months of open treatment with SR58611A (350 mg q12) - NA
sanofi-aventis recherche&developpement0 个研究点目标入组 800 人开始时间: 2006年2月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Out-patients 18 years old or more.
- •2. Patients suffering from Major Depressive Disorder, and presenting a Major Depressive Episode according to DSM-IV-TR criteria Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) and assessed with the Mini International
- •Neuropsychiatric Interview (MINI).
- •3. Recurrent episode, with either 2 or more previous episodes, or only one previous
- •episode but within the last 5 years.
- •4. The duration of the current episode is at least of 2 months.
- •5. With a total score on the Montgomery and Asberg Depression Rating Scale
- •(MADRS) = 28.
- •6. Patients have given voluntarily their written informed consent to participate in the
- •whole maintenance study.
- •7. Able to comply with the protocol and follow written and verbal instructions.
- •At Week 8, patients will be qualified for pursuing the study if:
- •MADRS < 12 (remission criterion).
- •At Week 34, improved patients will be randomized into the double-blind phase if they have:
- •a MADRS total score < 16 at W12, W18, W24 and W30,
- •and a MADRS score < 12 at W34.
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients at immediate risk for suicidal behavior based on an unstructured clinical
- •interview; or who have, before first study drug intake [at either the screening (V1) or
- •baseline (V2) visits]:
- •- A score of >5 on the suicidal thoughts item of the MADRS
- •- Or, a current suicide risk score =10 or high risk” on module C of the (MINI).
- •2. Patients with a major depressive episode with psychotic features, catatonic features, seasonal pattern or postpartum onset according to MINI at screening.
- •3. Patients with 3 or more episodes of depression in the last 3 years.
- •4. The course of the current depressive episode is longer than 2 years.
- •5. For the current episode, patients failed to respond to an adequate dose of an
- •antidepressant given for 6 weeks.
- •6. Patients with mood disorder due to general medical conditions (degenerative
- •neurological conditions, cerebrovascular disease, endocrine conditions, viral or other
- •infections).
- •7. Patients with a lifetime history according to MINI at screening of:
- •- bipolar disorder or psychotic disorder,
- •- antisocial personality disorder.
- •8. Patients with a current history according to MINI at screening of:
- •- alcohol dependence or abuse or substance dependence or abuse in the past
- •12 months, except nicotine or caffeine dependence,
- •- eating disorders.
- •9. Introduction of, or change in intensity of psychotherapy from 3 months prior to
- •10. Treatment with a MAO Inhibitor (during one week or more) within 2 weeks prior to screening.
- •11. Treatment with fluoxetine (during one week or more) within 4 weeks prior to
- •12. Chronic use of hypnotics / benzodiazepines. Chronic means more than 2 days per
- •week during the previous month.
- •13. Patients who have received Electro-Convulsive Therapy (ECT) for the previous Major Depressive Episode.
- •14. Patients who received any antipsychotic drugs in the last 4 weeks prior to screening.
- •15. Patients with severe or unstable concomitant medical conditions (cardiovascular,
- •neurologic, gastrointestinal, hepatic, renal, endocrinologic, rheumatologic) according
- •to the investigator's judgment that would impact the assessment of the study drug.
- •16. History of seizures other than a single childhood febrile seizure.
- •17. Patients with abnormal thyroid functioning, i.e. TSH blood level at screening out of normal range, unless patients are taking a hormone replacement therapy at a stable dose for at least 3 months prior to baseline.
- •18. Patients with clinically significant abnormal laboratory value at screening, e.g. ALT or AST > 2 times upper limit of normal range (ULN), hemoglobin < 12g / 100ml for
- •male and < 11g / 100ml for female, neutrophils < 1500/mm3, platelets < 100 000/mm3, creatinine = 150 µmol/l.
- •19. Patients with clinically significant ECG findings at screening.
- •20. Patients with positive results on the urine drug screen at screening.
- •21. Patients who have taken an investigational drug in the last 3 months prior to screening.
- •22. Any subject who has previously participated in a SR58611A protocol.
- •23. Women who are pregnant or breast-feeding; women of childbearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse: for example intrauterine device, oral contraceptives, implant, hormonal injection, barrier devices or barrier devices with spermicide.
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