Shortened LSD Intervention for Major Depressive Disorder
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to determine the safety and clinical effectiveness of a shortened lysergic acid diethylamide (LSD) experience. This will be achieved by administering the drug risperidone 45-minutes after the administration of LSD.
详细描述
This study will administer open-label oral LSD hemi-L-tartrate 250 µg followed 45 minutes later by oral risperidone 1 mg to 10 participants with Major Depressive Disorder (MDD) for a pilot investigation into the effects of abbreviated LSD on depression. Participants will be monitored for 10.5 hours and assessed for subjective effects and discharge readiness at several time points following the dose. The main aim of this study is to test whether risperidone can be used to abbreviate the subjective effects of LSD, and whether this abbreviated LSD experience will have any potential therapeutic benefit in patients with MDD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given written informed consent
- •Meet DSM-5 criteria for MDD
- •MADRS >= 28 at screening Can read, write, and speak English fluently
- •Be judged by study team clinicians to be at low risk for suicidality
排除标准
- •Women who are pregnant, nursing, or not practicing an effective means of birth control
- •Cardiovascular conditions: hypertension with resting blood pressure systolic >139 or diastolic >89, angina, heart rate > 99, a clinically significant ECG abnormality (e.g., atrial fibrillation, QTc > 450), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease, cardiac valvulopathy
- •Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- •Currently taking antipsychotics, or MAO inhibitors
- •Patients taking antidepressant medications and unable to taper
- •Moderate or strong CYP2D6 inhibitor antidepressants must undergo a washout period of 4 weeks or five half-lives prior to treatment
- •Currently taking CYP2D6 inhibitor other than an antidepressant that will be tapered
- •Currently taking efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag
- •Have a seizure disorder, multiple sclerosis, history of significant head trauma, CNS tumor, movement disorders or any neurodegenerative condition
- •Morbidly obese (>100 lbs. above ideal body weight, or BMI >=40, or BMI >=35 with high blood pressure or diabetes)
- •Be judged by a study team clinician to be at risk for moderate or severe alcohol or benzodiazepine withdrawal
- •Body weight < 45 kg
- •Significant acute adverse reaction (e.g., dystonia) to an antipsychotic
- •Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (including substance-induced), Bipolar I or II Disorder or Major
- •Depression with psychotic features
- •Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or Bipolar I Disorder.
研究组 & 干预措施
LSD + Risperidone
干预措施: Risperidone (Drug)
LSD + Risperidone
干预措施: LSD (Drug)
结局指标
主要结局
Change in Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: 1 month
Score range from 0 to 60. Higher scores indicate worse depression symptoms
次要结局
未报告次要终点