2023-506597-12-00招募中3 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 »
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Total score change of the Hamilton Depression Rating Scale (HDRS 17 items: scale items are rated from 0 to 2 or from 0 to 4 and the score ranges from 0 to 52) after 7 days of treatment
研究概览
简要总结
Objective For the main Study to compare early efficacy at day 7 on depressive symptoms of intravenous ketamine versus placebo on add on to venlafaxine in patients hospitalized for severe major depressive episode Objectives for ancillary study
- To compare synaptic density changes assessed by PET-MRI before (d0) and after (d14) early add on treatment of ketamine or placebo in patients hospitalized for severe major depressive episode.
- To assess whether clinical improvement after ketamine correlates with synaptic density changes
研究设计
- 分配方式
- Randomized
- 主要目的
- Moodbooster
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
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+ <
- •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
结局指标
主要结局
Total score change of the Hamilton Depression Rating Scale (HDRS 17 items: scale items are rated from 0 to 2 or from 0 to 4 and the score ranges from 0 to 52) after 7 days of treatment
Total score change of the Hamilton Depression Rating Scale (HDRS 17 items: scale items are rated from 0 to 2 or from 0 to 4 and the score ranges from 0 to 52) after 7 days of treatment
次要结局
- 1 et 4) Efficacy: assessed by 5 complementary criteria a) main criteria : Total score change of the Hamilton Depression Rating Scale (HDRS 17) b) response rate : ≥50% HDRS total score improvement c) remission : (HDRS 17 items ≤ 7) d) Beck Depression Inventory (BDI) change e) Clinical Global Impression rating scale (CGI)
- 2) hospital stay length ( the number of days spent in hospital, including re-hospitalization, during the fallow up 42 days). The end of the hospital stay is decided by the clinician blinded to treatment.
- 3) Total scores change on the Columbia Suicide Risk Scale (C-SSRS)
- 5) The safety assessed with Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The occurrence of adverse effects in the ketamine and placebo groups will be assessed by monitoring during the infusion of treatment or placebo and up to 40 minutes afterwards blood pressure, heart rate, respiratory rate, nausea/vomiting, dissociation, headache.
- 6) cumulative consumption in mg of cyamemazine over the entire study period
- 7) biomarkers predictive or associated with the efficacy of ketamine on add on to venlafaxine
研究者
Dr Romain COLLE
Scientific
Assistance Publique Hopitaux De Paris
研究点 (3)
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