EUCTR2009-010642-57-SK进行中（未招募）1 期
Efficacy and safety of ValdoxanR given orally once a day for 24 weeks in patients with Major Depressive Disorder.” Open, national, multicentric clinical trial for the evaluation of the antidepressant efficacy and tolerability of ValdoxanR and its additional clinical benefits for depressed patients.
Servier Slovensko, spol. s.r.o.0 个研究点目标入组 0 人开始时间: 2009年6月3日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Demographic characteristics
- •- Aged 18 to 65 years (inclusive)
- •- Male or female
- •- Outpatients
- •Diagnosis criteria - According to clinical examination in the phase of choice of the patients are verified following conditions:
- •- Clinical diagnosis of depressive disorder verified according to MINI criteria (Mini International Neuropsychiatric Interview). Present episode can have moderate or serious intensity, with or without symptoms of melancholic subtype of depressive episode, without psychotic symptoms and the beginning of episode can not correlate with postpartum period.
- •- MADRS score at least 20
- •- State, which demands the therapy with antidepressants
- •- Patient is not treated with antidepressants at the time of involvement in the study
- •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
- •General criteria
- •- Patients, which do not want to cooperate adequately or the patients in whom we can not expect sufficient compliance during the therapeutic period
- •- Patients, which will not be available for examinations like it is defined in protocol (for example holidays, ...)
- •Pregnant or breastfeeding women
- •Women, which can potentially get pregnant and the adequate contraception is not provided (per oral contraception, intrauterine device or using of condoms)
- •Involvement in other study at he same time or in the period of three months before involvement in study, or it is known, that the patient is involved in another study at the time of choice of patients
- •Medical and therapeutic criteria
- •Related to depression
- •- All types of depression other than major depressive disorder, including Bipolar Disorder I and II, Double Depression (MDD combined with Dysthymic Disorder), chronic depressive disorder (defined as an episode of depression with a duration longer than 2 years), Schizoaffective Disorder of the depressive type, depression with psychotic features.
- •- Dysthymic Disorder according to DSM IV criteria.
- •- Current depressive episode having not responded to two different previous antidepressant treatments given for at least 4 weeks at an appropriate dose.
- •- Marked suicidal intent and/or known suicidal tendencies for the current episode, based on item 10 of MADRS along with the investigator's opinion based on the patient’s medical history, previous suicide attempts, and quality of social and familial support.
- •- Patient treated with electroconvulsive therapy within the last 3 months before inclusion or requiring electroconvulsive therapy at present (according to investigator’s judgment).
- •- Insight-oriented and structured psychotherapy (interpersonal therapy, psychoanalysis, cognitive behavioral therapy) started within the 3 months before inclusion.
- •- Light therapy received within 2 weeks before inclusion.
- •Related to other psychiatric conditions
- •- Patients meeting DSM-IV diagnosis of current Panic Disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, acute Stress Disorder.
- •- Patients with acute or chronic psychotic disorder.
- •- Patients with antisocial, borderline, or histrionic personality disorders according to DSM IV criteria.
- •- Patients with a severe personality disorder other than antisocial, borderline, or histrionic and prone to interfering with the evaluation of the study according to the investigator’s judgment.
- •Related to miscellaneous conditions
- •- Alcohol or drug abuse or dependence within the past 12 months (excluding nicotine), as defined in DSM-IV.
- •- Hepatic impairment. (i.e. cirrhosis or active liver disease)
- •- ASAT, ALAT values > 2 times the upper reference value
- •- Delirium or dementia according to DSM-IV.
- •- Current diagnosis of neurological disorders: eg, stroke, seizures, migraine …
- •- Severe or uncontrolled organic disease likely to interfere with the conduct of the study (eg, neoplastic, cardiovascular, pulmonary and digestive disorders, unstabilized diabetes of type I or II, untreated or uncontrolled arterial hypertension).
- •- acute porphyria.
- •- Shift workers.
- •Conditions related to previous or present therapy - All treatment listed below should be stopped before the inclusion in the study with respect of the corresponding wash-out period:
- •- Antipsychotic drugs (including depot antipsychotic drugs, if they were administrated less then 2 months before involvement in study)
- •- Thymoprophyl
研究者
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