Phase 3 ADHD Trial, Recruiting NCT06931080 Sponsor: Otsuka Pharmaceutical Co., Ltd. Condition: ADHD
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Phase 3 ADHD Trial, Recruiting

NCT06931080
Recruiting Phase 3

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Status
Recruiting
Phase
Phase 3
Sponsor
Otsuka Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
30 April 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score at Week6

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov