Status:
COMPLETED
Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
Lead Sponsor:
Mind Medicine, Inc.
Conditions:
ADHD
Attention Deficit Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study measures the safety and efficacy of repeated low dose MM-120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled
Detailed Description
This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM-120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a 3/4-day schedul...
Eligibility Criteria
Inclusion
- Male and female outpatients ≥ 18 and ≤ 65 years of age at Screening
- Patients with the diagnosis of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) ADHD, as determined by clinical evaluation and confirmed by structured interview (MINI).
- Adequate organ function.
- Able to understand the study procedures and understand risks associated with the study, and sign written informed consent to participate in the study.
- Must be willing to refrain from more than 6 standard alcoholic drinks a week, more than 10 cigarettes a day, and more than 2 cups of coffee a day throughout the study treatment period (6 weeks) and until the last study visit is complete.
Exclusion
- Past or present diagnosis of a primary psychotic disorder or first degree relative with a psychotic disorder.
- Past or present bipolar disorder (DSM-5).
- Any lifetime history of suicide attempt.
- Once Informed Consent form is signed, not willing or able to stop any prescription or non-prescription ADHD medications.
- Use of investigational medication/treatment in the past 30 days.
- Patients with a positive urine drug screen with the exception of THC or its metabolites.
- Pregnant or nursing females.
Key Trial Info
Start Date :
December 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05200936
Start Date
December 17 2021
End Date
December 4 2023
Last Update
April 13 2025
Active Locations (2)
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1
Maastricht University
Maastricht, Netherlands
2
University Hospital Basel
Basel, Switzerland