NCT05200936 - Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial | Crick

Overview

This study measures the safety and efficacy of repeated low dose MM120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a 3/4-day schedule). Low dose MM120 (20 μg) is about 20% of the dose typically consumed for recreational psychedelic purposes. There will be a 1:1 randomization, double-blind, to MM120 or placebo with the aim to reach 26 evaluable patients in each of the 2 arms at Week 6.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

53

Conditions

ADHD Attention Deficit Disorder

Interventions

MM120DRUG

MM120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM120 manifests primarily visual, as well as auditory, hallucinations.

PlaceboOTHER

A treatment which is designed to have no therapeutic value.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

Maastricht University

Maastricht, Netherlands

University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms

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.

Time frame: 6 weeks

Secondary Outcomes

Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms

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.

Time frame: Week 2

Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)

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.

Time frame: Baseline, Week 2, Week 6, Week 10

Change From Baseline in in Clinical Global Impressions Scale (CGI-S)

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.