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Completed

NCT Number: NCT05200936

Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial

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

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Key information

Conditions

ADHD Attention Deficit Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maastricht University, Maastricht, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MM120

Drug

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.

Other names: MM-120, DT120, lysergide tartrate

Placebo

Other

A treatment which is designed to have no therapeutic value.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)

    Time frame: 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.

  5. Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)

    Time frame: 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.

  6. 5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores

    Time frame: 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.

  7. Mystical Experience Questionnaire 30 Items (MEQ30)

    Time frame: 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%).

  8. Summary of Drug Effects Visual Analog Scale (VAS)

    Time frame: 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.

Other outcomes

  1. Pharmacokinetic Outcomes

    Time frame: 0.5, 1, 2, 3, 4, 6 hours post-dose

    Maximum Plasma Concentration [Cmax] of MM-120 in the blood at Week 1 Day 1

  2. Pharmacokinetic Parameters (Cmax)

    Time frame: 0.5, 1, 2, 3, 4, 6 hours post-dose

    Maximum concentration (Cmax)

  3. Pharmacokinetic Parameters (Tmax and t1/2)

    Time frame: 0.5, 1, 2, 3, 4, 6 hours post-dose

    Time to maximum concentration (Tmax), half life (t1/2)

  4. Pharmacokinetic Parameters (AUC0-inf and AUC0-6h)

    Time frame: 0.5, 1, 2, 3, 4, 6 hours post-dose

    Area under the concentration curve from time 0 to infinity (AUC0-inf), Area under the concentration curve from time 0 to 6 hour (AUC0-6h)

Sponsors and collaborators

Lead sponsor

Definium Therapeutics US, Inc.

Industry

Registry information

Official study title

Safety and Efficacy of Repeated Low Dose d-Lysergic Acid Diethylamide (LSD) D-tartrate (MM120) as Treatment for ADHD in Adults: a Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2a Proof of Concept Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 21, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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