Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
ADHD,Attention Deficit Disorder
Age (in years)
18 - 65
Phase
Phase 2
Participants needed
53
Est. Completion Date
Dec 8, 2023
Treatment type
Interventional
Sponsor
Mind Medicine, Inc.
ClinicalTrials.gov identifier
NCT05200936
Study number
MMED007
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