Clinical trial NCT05200936: Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial
Official title: Safety and Efficacy of Repeated Low Dose d-Lysergic Acid Diethylamide (LSD) D-tartrate (MM-120) as Treatment for ADHD in Adults: a Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2a Proof of Concept Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ADHD
Attention Deficit Disorder
Lead sponsor: Mind Medicine, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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:

* 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.

Primary outcomes:
measure: Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms
timeFrame: Week 2
measure: Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)
timeFrame: Baseline, Week 2, Week 6, Week 10
measure: Change From Baseline in in Clinical Global Impressions Scale (CGI-S)
timeFrame: Baseline, Week 2, Week 6
measure: Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
timeFrame: 6 weeks
measure: Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)
timeFrame: 6 weeks
measure: 5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
timeFrame: 6 weeks
measure: Mystical Experience Questionnaire 30 Items (MEQ30)
timeFrame: 6 weeks
measure: Summary of Drug Effects Visual Analog Scale (VAS)
timeFrame: 6 hours
Other outcomes:
measure: Pharmacokinetic Outcomes
timeFrame: 0.5, 1, 2, 3, 4, 6 hours post-dose
measure: Pharmacokinetic Parameters (Cmax)
timeFrame: 0.5, 1, 2, 3, 4, 6 hours post-dose
measure: Pharmacokinetic Parameters (Tmax and t1/2)
timeFrame: 0.5, 1, 2, 3, 4, 6 hours post-dose
measure: Pharmacokinetic Parameters (AUC0-inf and AUC0-6h)
timeFrame: 0.5, 1, 2, 3, 4, 6 hours post-dose
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Maastricht University
name: Kim Kuypers
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Matthias Liechti
role: PRINCIPAL_INVESTIGATOR
References: