MM120 for Depression

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mind Medicine, Inc.

Disqualifiers: Psychiatric disorders, Psychotic, Bipolar, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

2 SuperSites 2 of this trial's clinics are recognized for rapid followup

5 Power Preferred Clinics 5 of this trial's clinics are considered top 20 on Power

Compensation: Varies

Number of Visits: 10

Duration: 52 weeks

140 Participants Needed

Trial Summary

What is the purpose of this trial?

To test whether an LSD-derivative can provide fast, long-lasting relief for depression symptoms.

Do I need to stop taking my current medications?

The trial's medical team will discuss with you which medications may need to be paused during the trial. Any changes to medication should be made under the supervision of a medical professional.

Eligibility Criteria

This trial is for individuals with Major Depressive Disorder. Participants must be adults and able to give informed consent. Specific medical conditions or medications may exclude some people, as determined by the study's detailed criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial (2-4 weeks)

2-4 weeks

Treatment

12-week randomized, double-blind, single dose administration and follow-up period evaluating MM120 versus placebo (12 weeks)

12 weeks

Open-label Extension

40-week extension phase with the opportunity for open-label treatment with MM120 (40 weeks)

40 weeks

Treatment Details

Interventions

• MM120 (LSD D-Tartrate)
• Placebo

Trial Overview The trial is testing MM120 (LSD D-Tartrate), an investigational study drug, against a placebo. It's in Phase 3, meaning it's already been through earlier trials for safety and effectiveness. Part A of the study is blinded so neither doctor nor patients know who gets what; Part B allows all participants to try MM120.

Participant Groups

Group I: Arm 2 - 100µg MM120 (LSD D-Tartrate) Experimental Treatment 1 Intervention

A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Group II: Arm 1 - Placebo Placebo Group 1 Intervention

A substance that is designed to have no therapeutic value

Who Is Running the Clinical Trial?

Mind Medicine, Inc.

Lead Sponsor

Trials

8

Recruited

1,500+