Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial

• Status: Recruiting
• Trial end date: 2023-11-27
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mind Medicine, Inc.

Criteria

Inclusion Criteria:

• Male and female outpatients ≥ 18 and ≤ 65 years of age.

• 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 final dose.

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.

• 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.

• Pregnant or nursing females.

• Non-German (Switzerland site) or non-Dutch (Netherlands site) speaking patients.