Attention-Deficit/Hyperactivity Disorder
Conditions
Interventions
Product Name: d-lysergic acid diethylamide
Pharmaceutical Form: Oral solution
INN or Proposed INN: LYSERGIDE
CAS Number: 50-37-3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentra
Sponsors
Mind Medicine, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 site 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 history of 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 3X ULN (except for Gilbert’s disease). o Any clinically significant abnormal metabolic or hematologic screen, per Investigator or medical supervisor decision. o Exclusionary blood pressure: > 140 mm Hg (systolic) or > 90 mm Hg (diastolic); heart rate 90 beats/minute after an approximately 5-minute supine or semi-supine rest. NOTE: If the first measurement of a subject’s heart rate is >90 beats/minute, a second recording is allowed after a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Mean change from baseline in ADHD symptoms, as assessed by the AISRS after 6 weeks of treatment. The AISRS total score consists of 18 items from the original Attention- Deficit/Hyperactivity Disorder - Rating Scale (ADHD-RS), which were derived based on DSM-5 criteria for ADHD. 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.;Main Objective: To assess the treatment efficacy vs placebo of repeated low doses (20 µg) of MM-120 for six weeks in adult subjects with ADHD measured by Adult Attention Deficit Investigator Symptom Rating Scale (AISRS).;Secondary Objective: 1. To assess treatment efficacy vs placebo measured by change from baseline in AISRS after 1 week of treatment. 2. To assess treatment efficacy vs placebo based on the proportion of subjects who experience at least a 1-point decrease in the Clinical Global Impression - Severity of Illness Scale (CGI-S). 3. To assess treatment efficacy vs placebo measured by change from baseline in CGI-S. 4. To assess the safety and tolerability by Adverse Event (AE) and Serious Adverse Event (SAE) assessment.;Timepoint(s) of evaluation of this end point: This end point will be evaluated after 6 weeks of dosing (12 administrations) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ADHD-related endpoints ? key secondary endpoint: change from baseline in AISRS after 1 week (2 doses) of treatment. ? occurrence of patients who experience at least a 1-point decrease in the CGI-S ? change from baseline in CGI-S after 1 week (2 doses) of treatment and after 6 weeks of treatment ? change from baseline in patient self-assessment by the Adult ADHD Self-Report Scale (ASRS) and Connors’ Adult ADHD Rating Scale (CAARS). Safety Endpoints ? Vital signs (supine blood pressure, heart rate) ? 12-lead safety ECG ? Adverse events (e.g., psychological and/or physiological adverse events) ? Columbia-Suicide Severity Rating Scale (C-SSRS) ? Safety laboratory evaluation and Urine pregnancy testing;Timepoint(s) of evaluation of this end point: This end point will be evaluated after 6 weeks of dosing (12 administrations) | — |
Countries
Netherlands, Switzerland
Contacts
Public ContactPrincipal Investigator
Maastricht University
Outcome results
None listed