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

Phase 2

Completed

Conditions: Attention Deficit Hyperactivity Disorder
ADHD

Registration Number: NL-OMON52408

Lead Sponsor: Mind Medicine, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

1. Ability and willingness to provide written, informed consent prior to
initiation of any
study-related procedures and to adhere to all study requirements.
NOTE: The subject (i.e., not a legally authorized representative) must be
cognitively
able to understand the requirements of the study and provide the informed
consent.
2. Age >= 18 and <= 65 years at screening.
3. Subjects 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).
4. AISRS total score of >=26 at screening.
5. CGI-S score of >=4 at screening.
6. Must be willing to receive IMP dose twice weekly. On Day 1, the subject will
come to
the clinic and must be willing to take a taxi or public transportation home or
be
accompanied by a caregiver and not drive a car, use heavy equipment, or
participate in
any other dangerous activity for the remainder of the day after receiving IMP
(NOTE:
at any protocol visit after Day 1 dosing, dosing visits may occur at the
subject*s home
at the discretion of the PI, conducted by one of the study investigators or
delegate and
administered under supervision followed by the performance of the same
procedures
done at the clinic including safety monitoring. If early withdrawal is
considered due to
any safety issue identified, the Sponsor*s medical monitor should be notified.
If a
remote visit is conducted due to any reason related to the COVID-19 pandemic,
notification must be sent to the Medical Monitor*s dedicated email address and
Urgent
Safety Measures as outlined in this protocol must be followed.)
7. Must be willing to refrain from more than 6 standard alcoholic drinks per
week
(1 standard drink corresponds to 0.1 L wine, 0.3 L beer, or 4 cL liquor), 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 (EoS or ET).

Exclusion Criteria

1. Past or present diagnosis of a primary psychotic disorder or first-degree
relative with a
psychotic disorder.
2. Past or present bipolar disorder (DSM-5).
3. Other current psychiatric disorders that, in the opinion of the Investigator
or medical
supervisor, may confound the results of the study (e.g., obsessive-compulsive
disorder,
dysthymic disorder, panic disorder, dissociative disorder, anorexia nervosa or
bulimia
nervosa).
4. Subjects with past (> 1 month prior to the screening visit) or present
substance use
disorder (except nicotine, provided subject does not smoke more than 10
cigarettes a
day).
5. Somatic disorders including Central Nervous System (CNS) involvement of
cancer,
severe cardiovascular disease, untreated hypertension, severe liver disease
(liver
enzyme increase by more than 3x the upper limit of normal except unconjugated
hyperbilirubinemia due to Gilbert*s Disease, per Investigator), severely
impaired renal
function (estimated creatinine clearance < 50 mL/min by CKD-EPI formula), or
anything else that, in the judgment of the Investigator or medical supervisor,
poses too
great a potential for side effects.
6. Any lifetime history of suicide attempt; or recent (within 6 months prior to
the screening
visit) active suicidal thoughts or ideation (defined as a suicidal ideation
score of 2 or
greater in the Columbia-Suicide Severity Rating Scale [C-SSRS]); or endorsement
of
any suicidal behavior on the C-SSRS within the past 6 months prior to the
screening
visit.
7. Likely to require psychiatric hospitalization during the course of the study.
8. Once consent is signed, subject not willing or able to stop any prescription
or nonprescription
ADHD medications during screening and prior to the baseline visit through
final study visit (EoS or ET). A list of prohibited medications is provided in
Appendix 1.
9. Plan to start, stop, or alter the use of any medications, supplements, or
other therapeutics
from Baseline until EoS or ET (see Appendix 1 for list of prohibited
medications).
10. Plan to start, stop or alter the use of psychotherapy, massage, meditation,
acupuncture,
hypnosis, yoga, or other similar therapy/activity from the time of providing
informed
consent until EoS or ET.
11. Use of potent CYP2D6 inhibitors; moderate CYP2D6 inhibitors by Investigator
discretion (see Section 5.5.1.1 and Appendix 3).
12. Likely to need use of any psychiatric medications with the potential to
confound
interpretation of study results or impact safety, at the discretion of the
Investigator, in
the 10 weeks following Baseline up to EoS or ET (see Appendix 1 for list of
prohibited
medications).
13. Use of investigational medication/treatment in the past 30 days prior to
the screening
visit.
14. Subjects with a positive urine drug screen (with the exception of THC or
metabolites)
at Screening OR Baseline.
15. Clinically significant abnormal baseline laboratory values, VSs, and ECG
that include
the following:
a. Have evidence of clinically significant hepatic disorder (e.g., alanine
aminotransferase [ALT] or aspartate aminotransferase [AST] > 3X ULN
(except for Gilbert*s disease), and
b. Any clinically significant abnormal metabolic or hematologic screen, per
Investigator or medical supervisor dec

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Mean change from baseline in ADHD symptoms, as assessed by the AISRS after 6<br /><br>weeks of treatment. The AISRS total score consists of 18 items from the<br /><br>original Attention- Deficit/Hyperactivity Disorder - Rating Scale (ADHD-RS),<br /><br>which were derived based on DSM-5 criteria for ADHD. The<br /><br>ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that<br /><br>address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to<br /><br>3. The AISRS total score can range from 0 to 54. A higher score corresponds to<br /><br>a worse severity of ADHD.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>ADHD-related endpoints:<br /><br>* key secondary endpoint: change from baseline in AISRS after 1 week (2 doses)<br /><br>of treatment.<br /><br>* occurrence of patients who experience at least a 1-point decrease in the CGI-S<br /><br>* change from baseline in CGI-S after 1 week (2 doses) of treatment and after 6<br /><br>weeks of treatment<br /><br>* change from baseline in patient self-assessment by the Adult ADHD Self-Report<br /><br>Scale (ASRS) and Connors* Adult ADHD Rating Scale (CAARS).<br /><br><br /><br>Safety Endpoints<br /><br>* vital signs (supine blood pressure, heart rate)<br /><br>* 12-lead safety ECG<br /><br>* psychological and/or physiological adverse events<br /><br>* Safety laboratory evaluation and Urine pregnancy testing<br /><br>* Columbia-Suicide Severity Rating Scale (C-SSRS)</p><br>