Phase 3 ADHD Trial, Recruiting

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

Who might be able to join this trial:

For people transferring from the earlier related trial (called "rollover participants"):

• People who completed the full 6-week treatment period and the 1-week follow-up in the earlier related trial, and who were not asked to stop taking the trial medication at the 6-week mark.
• People who did not have significant problems following the trial rules — such as taking the trial medication as instructed — during the earlier related trial.

For people joining for the first time (called "de novo participants"):

• People who have received a primary diagnosis of ADHD according to standard diagnostic guidelines (DSM-5), confirmed using a structured diagnostic interview called the MINI-KID, not including "other specified" or "unspecified" ADHD categories.
• People whose ADHD symptom score at the start of the trial is 28 or higher on a standard rating scale called the ADHD-RS-5.
• People whose ADHD severity is rated at 4 or higher by a clinician using a standard assessment tool called the CGI-S-ADHD at the start of the trial.

Who may not be able to join:

For people transferring from the earlier related trial (called "rollover participants"):

• People who have a positive pregnancy test at the start of the trial.
• People who experienced serious or severe side effects during the earlier related trial that were considered to be caused by the trial medication.
• People who, in the view of the trial doctor, are at significant risk of suicide — including anyone who indicated active thoughts of suicide on specific questions of a standardised safety scale (called the C-SSRS) during the earlier related trial.
• People who plan to take medications that are not permitted during the trial, or who used prohibited medications during the earlier related trial and where the trial doctor considers there is a chance this could happen again.

For people joining for the first time (called "de novo participants"):

• People who have a positive pregnancy test at the start of the trial.
• People who have been diagnosed with any of the following conditions, identified through the MINI-KID diagnostic interview: Tourette's disorder, panic disorder, conduct disorder, a psychotic disorder, post-traumatic stress disorder (PTSD), or bipolar disorder.
• People who have generalised anxiety disorder that requires medication treatment, as defined by standard diagnostic guidelines (DSM-5).
• People who have a diagnosis of autism spectrum disorder based on standard diagnostic guidelines (DSM-5).
• People whose main focus of treatment is a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder, based on standard diagnostic guidelines (DSM-5).
• People who have been diagnosed with major depressive disorder (MDD) and are currently experiencing a depressive episode, or who have needed treatment for MDD within the 3 months before screening — or where the trial doctor considers their depression may worsen or require treatment during the trial.
• People who have been diagnosed with an intellectual disability and have an IQ score below 70.
• People who, in the view of the trial doctor, are at significant risk of suicide — including anyone who indicated active thoughts of suicide on specific questions of a standardised safety scale (C-SSRS) in the 6 months before screening, or who has a history of suicidal behaviour in the past 6 months.
• People who have a diagnosis of substance use disorder.
• People whose blood test results at screening fall outside acceptable ranges — including low platelet counts, low haemoglobin, low neutrophil counts, elevated liver enzyme levels (AST or ALT), reduced kidney function, elevated muscle enzyme levels (CPK), or abnormal thyroid function (both free T4 and TSH) (confirm specific values with trial site).
• People who are not able or willing to stop taking medications that are not permitted during the trial, such as other ADHD medications or antidepressants.

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