MM120 for Generalized Anxiety Disorder

No longer recruiting at 28 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different doses of a new treatment, MM-120, might help individuals with generalized anxiety disorder (GAD) manage their symptoms. MM-120 is a psychoactive substance that affects serotonin receptors in the brain, which are linked to mood regulation. Participants will receive one of four different doses or a placebo (a substance with no active treatment) to determine the most effective dose. Those diagnosed with GAD and experiencing frequent anxiety may be suitable for this study, provided they meet other health and eligibility criteria. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of new anxiety treatments.

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.

Is there any evidence suggesting that MM-120 is likely to be safe for humans?

Previous studies have shown that MM-120, a form of LSD, is generally well-tolerated by patients. Research indicates that while some participants experienced mild side effects like nausea or headaches, these were usually not serious, and more serious side effects were rare.

The studies also examined the effects of different doses. Lower doses, such as 25 or 50 micrograms, typically resulted in fewer side effects compared to higher doses, like 200 micrograms. This suggests that the treatment might be safer at lower doses.

Overall, MM-120 has been used in past trials for generalized anxiety disorder and other conditions, providing some insight into its safety. However, this current trial aims to better understand the safety and effectiveness at different doses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anxiety?

Unlike the standard treatments for anxiety disorders, which often include SSRIs like sertraline and SNRIs like venlafaxine, MM-120 is a psychedelic compound derived from LSD. Most current anxiety treatments work by altering serotonin levels over time, but MM-120 acts directly as an agonist at the serotonin 2A receptor (5-HT2A), potentially leading to more immediate effects. Researchers are excited because this novel mechanism could offer rapid relief and benefits for patients who may not respond to traditional medications. With varying doses of MM-120 being tested, from 25 to 200 micrograms, there's an opportunity to fine-tune the treatment for optimal efficacy and minimal side effects.

What evidence suggests that MM-120 might be an effective treatment for anxiety?

Research has shown that MM-120, also known as lysergide, may help reduce anxiety in people with generalized anxiety disorder (GAD). In earlier studies, a single dose of MM-120 reduced anxiety, with higher doses often providing greater relief. This trial will test various dosages of MM-120, including 25 μg, 50 μg, 100 μg, and 200 μg, to evaluate their effectiveness in reducing anxiety. The treatment primarily affects a part of the brain involved in mood control. These findings suggest that MM-120 could be a helpful option for managing anxiety in people with GAD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40906494/

Single Treatment With MM120 (Lysergide) in Generalized ... Conclusions and relevance: In participants with moderate to severe GAD, a single dose of MM120 produced a dose-dependent reduction in anxiety. These results ...

2. ir.mindmed.co ir.mindmed.co/news-events/press-releases/detail/192/journal-of-the-american-medical-association-jama-publishes-results-from-first-ever-randomized-placebo-controlled-clinical-trial-assessing-the-dose-dependent-efficacy-of-mm120-lysergide-d-tartrate-lsd-in-generalized-anxiety-disorder-gad

Journal of the American Medical Association (JAMA ... MindMed is developing MM120, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), and is exploring its ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05407064

NCT05407064 | A Dose-Finding Study of MM-120 (LSD D- ... This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM-120 (25, 50, 100 or 200 μg ...

4. ama-assn.org ama-assn.org/about/publications-newsletters/can-psychedelic-help-treat-generalized-anxiety-disorder

Can a psychedelic help treat generalized anxiety disorder? Question: Does MM120 (lysergide D-tartrate) demonstrate dose-dependent efficacy in adults with moderate to severe generalized anxiety disorder?

5. jamanetwork.com jamanetwork.com/journals/jama/article-abstract/2838505

Single Treatment With MM120 (Lysergide) in Generalized ... Conclusions and Relevance In participants with moderate to severe GAD, a single dose of MM120 produced a dose-dependent reduction in anxiety.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06809595

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder ... The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension ...

7. horizonscandb.pcori.org horizonscandb.pcori.org/report/topics/974

MM120 (lysergide D-tartrate) to treat generalized anxiety ... MM120 (lysergide D-tartrate) to treat generalized anxiety disorder ... safety concerns. Many patients do not experience long-term symptom ...