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

Phase 2

Completed

Conditions: Attention Deficit Disorder
ADHD

Interventions: Other: Placebo
Drug: MM-120

Registration Number: NCT05200936

Lead Sponsor: Mind Medicine, Inc.

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 schedule).

Low dose MM-120 (20 μg) is about 20% of the dose typically consumed for recreational psychedelic purposes.

There will be a 1:1 randomization, double-blind, to MM-120 or placebo with the aim to reach 26 evaluable patients in each of the 2 arms at Week 6.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

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

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1- Placebo	Placebo	A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks.
Arm 2- MM-120	MM-120	A total of 26 patients will receive 20 μg of MM-120 administered orally twice weekly for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms	6 weeks	The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.

Secondary Outcome Measures

Name	Time	Method
Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms	Week 2	The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)	Baseline, Week 2, Week 6, Week 10	The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)	6 weeks	The Adult Attention-Deficit/Hyperactivity Disorder Self-Reporting Rating Scale (ASRS) is composed of 18 questions, and uses a scale that ranges from 0-4 based on the individuals mark in either the "never, rarely, sometimes, often, very often" column for a possible total score of 72. A higher score corresponds to a worse severity of ADHD.
Mystical Experience Questionnaire 30 Items (MEQ30)	6 weeks	The Mystical Experience Questionnaire 30 item (MEQ30) is a 30-item questionnaire rated on a six-point scale. The scale has been used to assess mystical experiences in studies using psilocybin and LSD. Higher scores = greater mystical experiences. The total score is expressed as a percentage of the maximum possible score (0 to 100%).
Summary of Drug Effects Visual Analog Scale (VAS)	6 hours	A series of single item visual Analog Scales (VAS) are used repeatedly 0 -6 hours after drug administration: The following 9 items were used in VAS (0-100 mm): "any drug effect", "good drug effect", bad drug effect", "drug liking", "fear", nausea", "alteration of vision", "alteration of sense of time", and "the boundaries between myself and my surroundings seem to blur". VAS scores range from 0 = no effect to 100 = strong effect. The scores for each item are extrapolated to a 100% scale and presented for each time point of assessment.
Change From Baseline in in Clinical Global Impressions Scale (CGI-S)	Baseline, Week 2, Week 6	The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.
Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)	6 weeks	The Connors' Adult ADHD Rating Scale (CAARS) Self-Report Long Form is a 66-item measure of ADHD symptom. Responses are scored on a 4-point scale, where 0 = not at all, 1 = just a little, 2 = pretty much, and 3 = very much. Item scores are summed to three main scores which are then transformed using population-derived age- and sex-adjusted norm values to a T-score. A T-score \< 60 indicates no ADHD. A T-score of 60-64 indicates borderline ADHD. A T-score of \> 64 indicates ADHD.
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores	6 weeks	The 5 dimensions of altered states of consciousness (5D-ASC) scale is a visual analog scale (VAS) consisting of 94 items each scored on a 0-100mm VAS extrapolated to 100% scale for quantitative evaluation. These 94 items are categorized into five dimensions: oceanic boundlessness (min:0, max:2700), anxious ego dissolution (min:0, max:2100), visionary destructuralization (min:0, max:1800), auditory alterations (min:0, max:1600), and vigilance reduction (min:0, max:1200). The total score is the sum of all questions and can range from 0 to 9400. Higher scores = more alteration in state of consciousness.