Phase 3 ADHD Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with ADHD (a specific type, not "other" or "unspecified" ADHD) based on a structured diagnostic interview using recognised criteria (DSM-5).
- If you are not currently taking ADHD medication, your ADHD symptom score on a standard rating scale must be 28 points or higher.
- If you are currently taking ADHD medication, your ADHD symptom score on a standard rating scale must be 22 points or higher.
Who may not be able to join:
- You are currently pregnant, breastfeeding, or test positive for pregnancy at the screening visit.
- You currently have another mental health condition that may need treatment with medications not allowed in this trial, or that could affect the trial results — for example, psychosis, bipolar disorder, generalised anxiety disorder, OCD, panic disorder, a current episode of major depression, or PTSD (confirm with trial site).
- You have been diagnosed with a personality disorder.
- You have been diagnosed with autism spectrum disorder.
- You have been diagnosed with an intellectual disability and have an IQ score below 70.
- You are considered to be at significant risk of suicide, including having had clear thoughts of suicide or a history of suicidal behaviour in the past 6 months, as assessed by a standard screening tool.
- You currently have, or have had in the past, a substance use disorder (not including tobacco-related issues).
- You have been diagnosed with an eating disorder or feeding disorder.
- You test positive for alcohol or drugs in screening tests.
- You have, or have had, certain neurological conditions, including epilepsy, seizures (other than childhood fever-related seizures), fainting episodes, Tourette's disorder, a significant head injury with loss of consciousness, dementia, stroke or other blood vessel problems in the brain, Parkinson's disease, lesions in the brain, or other serious neurological disorders.
- You have, or have had, a heart or cardiovascular condition.
- Your blood test results at screening show any of the following abnormal values: very low platelet count, low haemoglobin (anaemia), low white blood cell count, raised liver enzyme levels (AST or ALT), raised creatinine (a marker of kidney function), raised CPK (a muscle enzyme), or abnormal thyroid hormone levels (confirm with trial site for exact values).
- You are unwilling or unable to stop taking certain medications not allowed during the trial, such as ADHD medications or antidepressants.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Nobuhito Sanada, Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7314
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score at Week6
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.