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LSD derivative
MM120 for Generalized Anxiety Disorder
Verified Trial
Phase 2
Waitlist Available
Research Sponsored by Mind Medicine, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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?
Must not have
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?
Timeline
Screening 30 days
Treatment 1 day
Follow Up 12 days
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
MM120 is at a research stage, so it may have side effects that are not known at this time. As with any investigational new drug, there is a risk that unexpected adverse effects may occur. Almost all drugs, both old and new, can cause severe reactions. The possible mild to moderate side effects you may experience when receiving treatment with MM120 at 100 μg may include and typically resolve by end of session or within 24 hours of dosing: illusion (changes in how you see, hear, or feel things present around you), nausea, euphoric mood, headache, visual hallucination (seeing things that are not present), anxiety, excessive sweating by anxiety (anxiety hyperhidrosis), dilated pupils (Mydriasis), increased blood pressure, abnormal thinking, fatigue, and feeling unstable on your feet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 30 days1 visit
Treatment ~ 1 day1 visit
Follow Up ~ 12 days6 visits
Screening ~ 30 days
Treatment ~ 1 day
Follow Up ~12 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Assess the incidence of Adverse Events (AEs) and Serious Adverse Events (AEs)
Dose-Response
Improved Quality of Life as measured by EuroQol 5 Dimension 5 Level (EQ-5D-5L)
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 5- 200 μg MM-120 (LSD D-Tartrate)Experimental Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 Intervention
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
Group V: Arm 1- PlaceboPlacebo Group1 Intervention
A substance that is designed to have no therapeutic value.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MM-120 (LSD D-Tartrate)
2022
Completed Phase 2
~200
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Mind Medicine, Inc.Lead Sponsor
5 Previous Clinical Trials
957 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an acceptable overall medical condition to be safely enrolled into and to complete the study.You can swallow pills.You are able to swallow pills.You have been diagnosed with a specific type of anxiety disorder called DSM-5 generalized anxiety disorder.You have been diagnosed with a specific type of anxiety disorder called DSM-5 generalized anxiety disorder.You are able to provide informed consent.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2- 25 μg MM-120 (LSD D-Tartrate)
- Group 2: Arm 3- 50 μg MM-120 (LSD D-Tartrate)
- Group 3: Arm 4- 100 μg MM-120 (LSD D-Tartrate)
- Group 4: Arm 5- 200 μg MM-120 (LSD D-Tartrate)
- Group 5: Arm 1- Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 30 Days to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 Days
- Follow Ups: You may be asked to continue sharing information regarding the trial for 12 Days after you stop receiving the treatment.
Generalized Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05407064 — Phase 2