Phase 3 Schizophrenia Trial, Recruiting NCT06585787 Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company Condition: Schizophrenia
Back to Schizophrenia

Phase 3 Schizophrenia Trial, Recruiting

NCT06585787
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 between 55 and 90 years of age at the time of the initial screening visit.
  • People who have been diagnosed with Alzheimer's disease based on the 2024 revised diagnostic criteria set by the Alzheimer's Association Workgroup.
  • People who have had a brain scan (MRI or CT) within the past 5 years, taken at or after the time their dementia began, to rule out other brain conditions that could explain their symptoms.
  • People who have been experiencing psychotic symptoms (such as hallucinations or delusions, meeting specific international criteria) for at least 2 months before the screening visit — agitation may or may not also be present.

Who may not be able to join:

  • People whose psychotic symptoms are mainly caused by a condition other than Alzheimer's disease, such as schizophrenia, schizoaffective disorder, delusional disorder, or a mood disorder with psychotic features.
  • People who have had a major depressive episode with psychotic features in the 12 months before screening, or who have a history of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • People who have certain safety concerns identified through laboratory tests or other health checks (confirm with trial site for specific details).
  • Additional inclusion and exclusion criteria apply beyond those listed here (confirm with trial site).

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 22 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: Bristol-Myers Squibb, Bristol-Myers Squibb

Phone: 855-907-3286

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
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Registry
ClinicalTrials.gov
Start date
26 September 2024
Est. completion
24 November 2026

Where this trial is recruiting

🇦🇷 Argentina 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇳 China 🇭🇷 Croatia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇷🇴 Romania 🇷🇸 Serbia 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇺🇦 Ukraine 🇺🇸 United States

Primary endpoints

Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score

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: 22 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