Phase 3 ADHD Trial, Recruiting NCT07086313 Sponsor: Otsuka Pharmaceutical Co., Ltd. Condition: ADHD
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Phase 3 ADHD Trial, Recruiting

NCT07086313
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 officially diagnosed with ADHD (and not a vague or unclear form of it) based on standard diagnostic guidelines, confirmed through a structured interview.
  • Your ADHD symptoms score at least 28 out of a possible total on a standard rating scale at the start of the trial (called "baseline"), or at least 22 if you are already taking ADHD medication — measured during an earlier screening visit.
  • Your ADHD symptoms still score at least 28 on that same rating scale at the baseline visit.
  • A doctor has rated your ADHD as at least moderately severe (a score of 4 or higher) on a standard clinical scale at the baseline visit.

Who may not be able to join:

  • You are pregnant (based on a positive pregnancy test at the baseline visit).
  • You have been diagnosed with any of the following conditions: Tourette's disorder, panic disorder, conduct disorder, a psychotic disorder, post-traumatic stress disorder (PTSD), or bipolar disorder.
  • You have generalised anxiety disorder that requires medication to treat.
  • You have been diagnosed with autism spectrum disorder.
  • Your main focus of treatment is a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder (OCD).
  • You have been diagnosed with major depression and are currently in a depressive episode, have needed treatment for it in the past 3 months, or a doctor thinks your depression may get worse during the trial.
  • You have an intellectual disability with an IQ score below 70.
  • You are considered to have a significant risk of suicide, including if you have had certain suicidal thoughts or behaviour in the past 6 months (as measured by a standard safety questionnaire).
  • You have been diagnosed with a substance use disorder.
  • Your blood test results fall outside acceptable ranges, including low platelet count, low haemoglobin, low neutrophil count, abnormal liver enzyme levels, reduced kidney function, high muscle enzyme levels (with some exceptions — confirm with trial site), or abnormal thyroid test results.
  • You are unable or unwilling to stop taking certain medications that are 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 27 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
3 September 2025
Est. completion
1 August 2027

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Change from baseline in ADHD-RS-5 symptom total raw score at Week 6.

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: 27 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