CTIS2023-506597-12-00进行中（未招募）1 期
MOODBOOSTER« Early efficacy of ketamine compared to placebo, in add-on therapy of venlafaxine for inpatients with severe unipolar major depressive episodes: a double blind randomized controlled trial » - APHP220668
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Current MDE in the context of Major Depressive Disorder (DSM-5 criteria), hospitalized (open care) for this episode, with a minimum HDRS score of 24 and in the context of an indication for the introduction of venlafaxine treatment., Patient aged between 18 and 65, Signed free and informed consent, Membership of a social security scheme, For women of childbearing age, effective contraception throughout study participation
排除标准
- •Criteria relating to associated pathologies entailing particular risks: pharmaco-resistant MDE (failure of at least two properly conducted treatments with two different antidepressant treatment classes), MDE with psychotic features, psychotic disorder, bipolar disorder, current (<1 month) substance use disorder (excluding tobacco, Participating in other interventional research involving the human body or within the exclusion period following previous research involving the human body, if applicable, Social insurance, Liver impairment (AST and/or ALT > 3 ULN, PAL and/or GGT and/or bilirubin > 2 ULN), Severe renal insufficiency (GFR <30ml/min with Cockcroft's formula), Contraindication to ketamine : Hypersensitivity to active substance or excipients, comatose state, central nervous system (CNS) depression, Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, known prolongation of the QTc interval (>450ms for men and >470ms for women) or congenital long QT syndrome, recent acute myocardial infarction, uncompensated heart failure, history of ventricular arrhythmias or torsades de pointes, uncorrected hypokalemia (K+ < 3. 5 mmol/l), epilepsy, uncontrolled hypertension, porphyria., Contraindication to venlafaxine (hypersensitivity to venlafaxine or excipients, unstable hypertension, no indication for venlafaxine treatment in clinician's opinion due to ineffectiveness or tolerability of previous venlafaxine treatment)., Current or previous treatment with venlafaxine or ketamine in the month prior to study inclusion, Need to maintain another antidepressant, MAOI, Millepertuis or benzodiazepines (cyamemazine is permitted), Pregnant or breast-feeding patients (women of childbearing potential must have a negative urine or blood test for human chorionic gonadotropin prior to trial entry). Planned pregnancy within three months of enrolment, Adult under guardianship, curatorship, or safeguard of justice
研究者
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