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Not yet recruitingPhase 1

Shortened LSD Intervention for Major Depressive Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a shorter LSD experience is safe and helps people with major depression. Participants receive risperidone 45 minutes after LSD to shorten the experience.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give written consent to join the study.
  • Have major depressive disorder, as defined by standard mental health guidelines.
  • Score 28 or higher on the MADRS, a scale that measures depression symptoms, at screening.
  • Read, write, and speak English fluently.
  • Be judged by the study team to have a low risk of suicide.

Who can't join

  • Be pregnant, breastfeeding, or a woman not using effective birth control.
  • Have certain heart or blood vessel problems, including blood pressure above 139/89, a resting heart rate above 99, certain abnormal heart tests, or a recent mini-stroke.
  • Have seizures, multiple sclerosis, a serious past head injury, a brain or spinal cord tumor, a movement disorder, or a disease that damages nerve cells over time.
  • Have diabetes requiring insulin, or past low blood sugar while taking diabetes pills. Weigh under 45 kg (about 99 pounds), or meet the study’s limits for very high body weight.
  • Have a current or past psychotic disorder, such as schizophrenia; bipolar I or II disorder; or depression with psychosis, such as seeing things that are not there. Certain close family histories of psychotic disorders or bipolar I also rule you out.
  • Be judged at risk of moderate or severe withdrawal symptoms from alcohol or benzodiazepines, medicines often used for anxiety or sleep.
  • Take medicines barred by the study, including antipsychotics, MAO inhibitors, and certain medicines that affect how the body breaks down drugs. Antidepressants must be reduced and stopped as required; some need a waiting period before treatment.
  • Have had a serious sudden reaction to an antipsychotic medicine, such as muscle spasms.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Epilepsy * 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.

Study sites (1)

MD