Phase 4 ADHD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who scored above 3 on both the severity and interference sections of a fatigue questionnaire called the Fatigue Symptom Inventory at their screening visit.
• People who scored above 36 on a standard ADHD rating scale (ADHD-RS-IV) at their screening visit.
• People who meet the clinical criteria for an ADHD diagnosis, as assessed using a structured diagnostic interview (SCID-5 ADHD module) at screening.
• People who are between 18 and 65 years of age at the time of giving consent.
• People who are sexually active and able to become pregnant, or male partners of people who can become pregnant, must agree to use two forms of birth control or remain abstinent throughout the trial and for 30 days after it ends; women who could become pregnant must also test negative for pregnancy at screening.
• People who live within the state of Michigan for the full duration of the trial, or who live in a neighbouring state within 50 miles (one-way) of the study site.
• People who are able to swallow tablets whole.
• People who, in the investigator's opinion, are able to understand and follow the study requirements, including taking medication as directed and stopping any prohibited medications.
• People who have at least a basic level of intellectual functioning, without evidence of a significant general intellectual deficit, as determined by the lead investigator (note: specific learning disorders are not considered a general intellectual deficit).
• People who are able to provide written, signed, and dated consent to participate in the study.
• People who are fluent in English and able to communicate clearly with the investigator and study coordinator.
• People who test negative for methamphetamine, cocaine, and other illegal substances (illegal for recreational use in Michigan) at screening — cannabis is excluded from this requirement due to its legal status in Michigan; people taking prescription or over-the-counter medications that show up on a drug screen may need to complete a washout period as directed by the investigator.
• People who scored 4 or higher on a clinical severity rating scale (CGI-S) at screening.

Who may not be able to join:

• People who are immediate family members of the investigator or anyone directly involved in running the study.
• People who have taken part in another clinical trial or received an unapproved drug within the 30 days before screening.
• People who have medical complications related to being severely underweight or overweight.
• People who have an uncontrolled psychiatric condition (other than ADHD) that is causing significant symptoms or requires a medication or treatment program that is not permitted in this trial (reviewed case by case by the investigator).
• People who are currently considered a suicide risk, have made a suicide attempt in the past two years, or currently have thoughts of suicide with a plan or intent to act on them.
• People who have a history of substance abuse or drug dependence (as defined by DSM-5 criteria) within the past year, not including nicotine or caffeine.
• People who test positive for an illicit substance at the time of screening.
• People who have a serious, unstable, or chronic medical condition — including heart, kidney, liver, lung, or blood disorders, narrow-angle glaucoma, or other unstable medical or psychiatric conditions — that the investigator believes would make participation unsafe or likely result in hospitalisation; people with a history of intellectual impairment or severe learning disability are also excluded.
• People who have a history of seizure disorder (other than childhood febrile seizures), any tic disorder, a personal diagnosis of Tourette's disorder, or a family history of Tourette's disorder.
• People who have a history of heart disease, including coronary artery disease, heart attack, angina, irregular heartbeat, heart failure, valve disease, or congenital heart conditions.
• People who the investigator believes are likely to start new psychiatric medications (beyond their current regimen or the study drug) during the course of the trial.
• People who have previously been enrolled in this study.
• People who are planning to move outside the geographic area of the study site, or who have travel plans that would conflict with the required study visit schedule.
• People who are currently taking medications that cannot be stopped before starting the study drug, including stimulants, certain drugs affecting brain chemistry, or medications that may interact with the study drug Dyanavel XR — this is reviewed case by case by the investigator; stimulant medications must be stopped before the trial begins.
• People who have a known allergy, hypersensitivity, intolerance, or documented history of not responding to amphetamine-based medications.
• People who the investigator considers unsuitable for any other reason.
• People who have taken a type of medication called an MAOI within 14 days before the study begins.
• People who are currently on a medication regimen that the investigator believes would likely interfere with the study drug's effectiveness or the reliability of the study results.
• People who have taken central nervous system (CNS) stimulant medications within the past 3 months.

Important: Always verify eligibility with the trial site directly before applying.