ADHDPhase 2NCT05200936
Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial
A Phase 2 study testing MM120 in people with ADHD and Attention Deficit Disorder, run by Definium Therapeutics US, Inc. at 2 sites in 2 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD, Attention Deficit Disorder
- What is being tested?
- MM120
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Dec 2021to 4 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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
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
Read the detailed description
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.
- Conditions
- ADHD, Attention Deficit Disorder
- Being tested
- MM120, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM120Drug
Also called MM-120, DT120, lysergide tartrate
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- Placebo | Placebo comparator | 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. Receives: Other: Placebo |
| Arm 2- MM120 | Experimental | A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks. Receives: Drug: MM120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 6
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
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.
Measured: 6 weeks
Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)
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.
Measured: 6 weeks
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
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.
Measured: 6 weeks
Mystical Experience Questionnaire 30 Items (MEQ30)
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%).
Measured: 6 weeks
Summary of Drug Effects Visual Analog Scale (VAS)
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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start17 Dec 2021
- Primary completion6 Nov 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Definium Therapeutics US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim Kuypers, Principal investigator, Maastricht UniversityMatthias Liechti, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200936
- Sponsor's protocol ID
- MMED007
- Status last verified
- Mar 2025
- First submitted
- 21 Dec 2021
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haijen-Bongers ECHM, Hurks PPM, Schepers J, Vizeli P, Santos de Jesus J, Mueller L, Schmid Y, Liechti ME, Kuypers KPC. Effects of repeated low-dose LSD on neuropsychological functioning in adults with ADHD: a randomized placebo-controlled study. Psychopharmacology (Berl). 2026 Jun 20. doi: 10.1007/s00213-026-07107-7. Online ahead of print.
PubMed 42322409Mueller L, Santos de Jesus J, Schmid Y, Muller F, Becker A, Klaiber A, Straumann I, Luethi D, Haijen ECHM, Hurks PPM, Kuypers KPC, Liechti ME. Safety and Efficacy of Repeated Low-Dose LSD for ADHD Treatment in Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Jun 1;82(6):555-562. doi: 10.1001/jamapsychiatry.2025.0044.
PubMed 40105807
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05200936
- Acronym / sponsor ID
- MMED007
- Conditions
- ADHD, Attention Deficit Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Definium Therapeutics US, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Posted 13 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1- Placebo | Placebo comparator | Other: PlaceboA 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- MM120 | Experimental | Drug: MM120A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MM120Also: MM-120, DT120, lysergide tartrateMM120 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. | Drug | Arm 2- MM120 |
| PlaceboA treatment which is designed to have no therapeutic value. | Other | Arm 1- Placebo |
Primary outcome
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.
8 secondary outcomes
Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms
Time frame: Week 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
Change From Baseline in in Clinical Global Impressions Scale (CGI-S)
Time frame: Baseline, Week 2, Week 6
Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS)
Time frame: 6 weeks
Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS)
Time frame: 6 weeks
5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores
Time frame: 6 weeks
Mystical Experience Questionnaire 30 Items (MEQ30)
Time frame: 6 weeks
Summary of Drug Effects Visual Analog Scale (VAS)
Time frame: 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42322409Haijen-Bongers ECHM, Hurks PPM, Schepers J, Vizeli P, Santos de Jesus J, Mueller L, Schmid Y, Liechti ME, Kuypers KPC. Effects of repeated low-dose LSD on neuropsychological functioning in adults with ADHD: a randomized placebo-controlled study. Psychopharmacology (Berl). 2026 Jun 20. doi: 10.1007/s00213-026-07107-7. Online ahead of print.
- Derived from this study: PubMed 40105807Mueller L, Santos de Jesus J, Schmid Y, Muller F, Becker A, Klaiber A, Straumann I, Luethi D, Haijen ECHM, Hurks PPM, Kuypers KPC, Liechti ME. Safety and Efficacy of Repeated Low-Dose LSD for ADHD Treatment in Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Jun 1;82(6):555-562. doi: 10.1001/jamapsychiatry.2025.0044.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Kuypers principal investigator
Maastricht University
Matthias Liechti principal investigator
University Hospital, Basel, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MM120 in people with ADHD and Attention Deficit Disorder, run by Definium Therapeutics US, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05200936, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.