Phase 1 Schizophrenia Trial, Recruiting NCT07615426 Sponsor: Janssen Research & Development, LLC Condition: Schizophrenia
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Phase 1 Schizophrenia Trial, Recruiting

NCT07615426
Recruiting Phase 1

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 have been diagnosed with schizophrenia (confirmed through a specific psychiatric interview called the MINI) and whose condition is currently stable
  • People who are taking one atypical antipsychotic medication only, at a dose that has not recently changed
  • People who are currently receiving outpatient mental health care for schizophrenia from a psychiatric provider at the time of screening
  • People whose antipsychotic medication is confirmed to be present in their blood at the baseline visit, based on a blood test taken at screening
  • People who, if taking an antidepressant or anti-anxiety medication, have not had any dose changes in the 8 weeks before screening and will not have dose changes during the main treatment period

Who may not be able to join:

  • People who have ever been diagnosed (now or at any point in their lifetime) with certain other mental health conditions, including intellectual disability, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, unspecified psychotic disorder, substance-induced psychotic disorder, bipolar disorder, or recurring or current major depressive disorder
  • People who have had a moderate to severe problem with substance use — including alcohol — in the 6 months before screening (this does not apply to nicotine or caffeine)
  • People who have used cannabis (marijuana or similar) more than 3 to 5 times in the past 30 days
  • People who have had a stomach ulcer in the past 6 months, a history of upper gastrointestinal bleeding at any point in their life, an untreated H. pylori infection, or a diagnosis of Zollinger-Ellison syndrome
  • People who are currently experiencing thoughts or intentions of harming others, as assessed by the trial investigator

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 15 July 2026
Phase 1: approximately ~10% 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: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

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 1
Registry
ClinicalTrials.gov
Start date
2 March 2026
Est. completion
21 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Screen Pass Rate; Exploratory Assessment-Specific Completion Rate; Total Assessment Completion Rate; Study Completion Rate; Adverse Events (AEs) Including AEs of Special Interest (AESI); Number of Participants with Abnormalities in Vital Signs; Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG); Number of Participants with Abnormalities in Laboratory Parameters; Number of Participants Reporting Changes in Body Weight; Number of Participants Reporting Changes in Body Mass Index (BMI); Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time; Extr...

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: 15 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