2024-512559-20-00撤回3 期
The additive effect of ketamine in combination with electroconvulsive stimulation (ECS) in major depressive disorder (MDD): a translational study
Universita' Vita-salute S. Raffaele1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary endpoint is the mean change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to Day 28 (Week 4). This will assess the short-term efficacy of the treatment.
研究概览
简要总结
The primary objective of this study is to identify the phenotypic and neurochemical determinants of response to ketamine and electroconvulsive therapy (ECT) in patients with treatment-resistant major depressive disorder (MDD).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male and Female, aged 18-
- •Women of childbearing potential (WOCBP) must use at least 1 highly effective method of contraception. Highly effective methods of contraception are those which have a failure rate of <1% (when implemented consistently and correctly) and include: Intrauterine device (IUD), Bilateral tubal ligation, bilateral salpingectomy, or bilateral tubal occlusive procedure, Hormonal contraceptives (eg, oral, patch, or injectable), A double-barrier protection method (eg, condom, sponge, or vaginal diaphragm with spermicide cream, foam, or gel); abstinence from heterosexual intercourse is accepted if this is the participant’s usual lifestyle.
- •Diagnosed with major depressive disorder (according to SCID5-CV scale).
- •Affected by treatment resistant depression (defined as at least 2 different antidepressant agents used without success).
- •Adequacy of the score for anesthesia.
排除标准
- •Chronic neurological disease.
- •Participants with a known hypersensitivity to ketamine or any of its excipients will be excluded from the study
- •Participants with any contraindications to the use of ketamine, such as a history of severe cardiovascular conditions (e.g., uncontrolled hypertension, significant arrhythmias), intracranial hypertension, or severe liver impairment, will also be excluded to prevent potential adverse events.
- •Intellectual disability
- •Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurysm, endocrine disorders, neuromuscular diseases, space occupying brain lesions, stroke in the last 6 months),
- •Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, implantable electronic devises, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurism, endocrine disorders, neuromuscular disease, space-occupying brain lesions, stroke in the last 6 months).
- •Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year,
- •Pregnancy and lactation
- •Cardiovascular conditions
- •Psychiatric Disorders
- •Hepatic impairment
结局指标
主要结局
The primary endpoint is the mean change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to Day 28 (Week 4). This will assess the short-term efficacy of the treatment.
The primary endpoint is the mean change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to Day 28 (Week 4). This will assess the short-term efficacy of the treatment.
次要结局
- The secondary endpoints include the mean change in MADRS scores from baseline to Week 12, which will evaluate the long-term effects of the treatment. Additionally, cognitive outcomes will be assessed at both Day 28 and Week 12 to examine the impact of the treatment on cognitive function.
研究者
Danilo De Gregorio
Scientific
Universita' Vita-salute S. Raffaele
研究点 (1)
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