MM120 for Generalized Anxiety Disorder

Recruiting at 27 trial locations

Overseen By Mind Medicine

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mind Medicine, Inc.

Disqualifiers: Pregnancy, Breastfeeding, Schizophrenia, Bipolar, Suicide risk, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

198 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether MM120 (LSD) can help people with generalized anxiety disorder. The study examines the effects of MM120 on generalized anxiety disorder. LSD affects the brain's serotonin system, potentially altering mood and anxiety. LSD was investigated for MDD, anxiety, and severe somatic disorders.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, supplements, or other treatments that are not allowed during the study.

Eligibility Criteria

This trial is for adults with Generalized Anxiety Disorder who are in good health and have a BMI between 18 and 38 mg/kg2. It excludes those with certain psychiatric disorders or family history of them, pregnant or breastfeeding women, men unwilling to use contraception, anyone at significant suicide risk or taking prohibited medications.

Inclusion Criteria

Are you willing to avoid cannabis use during this 4 month study?

Do you have a friend or family member who will be able to meet you at the study clinic and drive you home after your single dosing day?

Exclusion Criteria

Have you ever been diagnosed with PTSD?

Have you or an immediate family member (child, sibling, parent) ever been diagnosed with Schizophrenia or Bipolar Disorder?

Have you used psychedelics in the past 2 years? e.g. LSD, MDMA, DMT, psilocybin, ayahuasca, mescaline, mushrooms, ecstasy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive one of four doses of MM-120 or placebo for the treatment of anxiety symptoms

12 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• MM-120

Trial Overview MM120 is a study drug that acts on serotonin in your brain. Researchers believe that MM120 could have possible benefits that may improve your general anxiety symptoms.

Participant Groups

Group I: Arm 5- 200 μg MM-120 (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 4- 100 μg MM-120 (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 III: Arm 3- 50 μg MM-120 (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 IV: Arm 2- 25 μg MM-120 (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 V: 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+