Phase 3 Schizophrenia Trial, Recruiting NCT07225712 Sponsor: Otsuka Pharmaceutical Co., Ltd. Condition: Schizophrenia
Back to Schizophrenia

Phase 3 Schizophrenia Trial, Recruiting

NCT07225712
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:

  • People who are Japanese, male or female, and aged 18 or older at the time of signing the consent form
  • People who have been diagnosed with schizophrenia according to a standard diagnostic system called the DSM-5
  • People whose condition has been considered clinically stable by the investigating doctor for at least 8 weeks before the screening visit
  • People whose schizophrenia symptom scores fall within a certain range (assessed using two rating scales called PANSS and CGI-S) at both the screening and baseline visits (confirm with trial site)
  • People whose antipsychotic medication has not changed for at least 6 weeks before screening, aside from small dose adjustments for tolerability

Who may not be able to join:

  • People who have been admitted to a psychiatric hospital within the 8 weeks before screening
  • People whose psychiatric symptoms did not improve despite trying two or more antipsychotic medications at appropriate doses for at least 4 weeks each, within the year before screening
  • People who have previously been treated with a medication called clozapine
  • People who are unwilling or unable to follow the trial's rules about which medications and therapies are allowed or prohibited during the study period

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
22 December 2025
Est. completion
1 March 2028

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

・Incidence of treatment-emergent adverse events (TEAEs)

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