EUCTR2006-003658-47-FR进行中（未招募）1 期
Exploratory study of the efficacy and safety of flexible doses of Milnacipran and Venlafaxine administered in out patients with Major Depressive Disorder.
Pierre Fabre Médicament - IRPF0 个研究点目标入组 180 人开始时间: 2006年8月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
入选标准
- •- Out patient, aged 18 years to 70 years
- •- Male, or female of childbearing potential using a medically accepted and well documented method of contraception (e.g. oral contraceptives, intrauterine devices, patch, contraceptive implant...) during 2 months before the inclusion in the study, documented sterility or postmenopause (one year amenorrhoea)
- •- Meeting DSM IV-TR criteria for Major Depressive Disorder diagnosed using a structured interview (MINI) moderate or severe, recurrent, unipolar, without psychotic features
- •- Total score MADRS > or = to 23 at selection and inclusion visits
- •- Without any clinically relevant abnormalities in clinical examination, laboratory tests and ECG parameters
- •- Patient having signed the written informed consent
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Psychiatric criteria
- •- Patient at significant suicidal risk as assessed with the MINI 5.0.0 - section C
- •- Resistance to two well-conducted antidepressant treatments (defined by the lack of response to at least two treatments prescribed at their optimal dose and during at least 4 weeks) for the current episode
- •- Any history of psychotic episode or disorder
- •- Any history of bipolar disorder
- •- Any current panic disorder, agoraphobia, or obsessive compulsive disorder, generalised anxiety disorder or post traumatic stress disorder whose onset preceded the onset of the depressive disorder (diagnosis confirmed with MINI) .
- •- Current major personality disorder of clinical significance or any other condition that might affect compliance (Cluster A, B and C ex: borderline, paranoid, histrionic, avoidant…)
- •- History of alcohol and/or drug abuse and/or dependence, except tobacco according to DSM IV-TR criteria in the 12 months preceding inclusion
- •Somatic criteria
- •- Severe underlying or ongoing systemic disease that could interfere with the study
- •- Fibromyalgia or chronic fatigue
- •- Previous history of generalised or partial seizure
- •- Organic cerebral disease
- •- Known closed angle glaucoma
- •- Cardiovascular disease including recent myocardial infarction, cardiac failure, post stroke, uncontrolled arterial hypertension
- •- Known cardiac rhythm or conduction disorder
- •- Hepatic insufficiency
- •- Known prostatic disorder and/or dysuria
- •- Renal failure
- •- Pregnancy or breast-feeding
- •- Gastrointestinal disorders (due to glucose and galactose malabsorption or lactase deficit) or congenital galactosemia
- •- History of hemostasis disorders.
- •Laboratory criteria
- •- AST/SGOT and ALT/SGPT greater than 1.5 times the upper normal values
- •- Creatinine > 150 µmol/L or documented creatinine clearence< 60 ml/min
- •- Positive pregnancy test
- •- Clinically relevant abnormal values according to the investigator's opinion for the other laboratory parameters
- •ECG criteria
- •- QT or QTc greater than the upper limit of the normal range
- •- Clinically relevant abnormal values according to the investigator's opinion for the other ECG parameters
- •Treatment related criteria
- •- Known hypersensitivity or allergy to one of the study treatments
- •- Non-response to milnacipran or venlafaxine for a previous episode
- •- Previous treatment with Milnacipran or Venlafaxine for this episode
- •- Patient involved in any other biomedical research currently or within the past 3 months
- •- Electroconvulsive therapy in the 3 months preceding inclusion
- •- Structured psychotherapy initiated within the past 6 weeks
- •- Treatment with a depot-neuroleptic during the past 12 months
- •- Chronic use (at least 5 days per week) of benzodiazepines in the past 3 months or initiation within the 3 months prior to D1, at doses strictly superior to 10 mg diazepam/day equivalent.
- •- Chronic use (at least 5 days
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