LSD + Risperidone for Depression

(SLIM Trial)

Overseen By Matthew Nielsen, BA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Antipsychotics, MAO inhibitors

Disqualifiers: Cardiovascular conditions, Epilepsy, Diabetes, Seizure disorder, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sandeep Nayak, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Inclusion Criteria

Have given written informed consent

I have been diagnosed with major depressive disorder.

MADRS >= 28 at screening

Exclusion Criteria

Women who are pregnant, nursing, or not practicing an effective means of birth control

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

I am currently taking antipsychotic medications or MAO inhibitors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label oral LSD followed by risperidone to assess the effects on depression

1 day

1 visit (in-person)

Monitoring

Participants are monitored for subjective effects and discharge readiness for 10.5 hours post-dose

10.5 hours

Continuous monitoring during treatment visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• LSD
• Risperidone

How Is the Trial Designed?

Group I: LSD + Risperidone Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+