Phase 3 Schizophrenia Trial, Recruiting NCT04411225 Sponsor: University of California, San Diego Condition: Schizophrenia
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Phase 3 Schizophrenia Trial, Recruiting

NCT04411225
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 have experienced a first episode of psychosis that began within the last 2 years, or who have an attenuated (mild/early) psychosis syndrome, and whose condition has been stabilised with treatment for at least 8 weeks
  • People who have been clinically stable and not in an acute (crisis) phase of their illness for at least 2 months
  • People with a first episode of psychosis who have been on their current antipsychotic medication for at least 6 weeks, with no change in dose for the past 4 weeks
  • People with attenuated psychosis syndrome who have been on the same treatment plan (whether therapy-based or medication-based) for at least 4 weeks
  • People whose positive symptoms (such as delusions, hallucinations, or disorganised thinking) are no more than moderate in severity, based on a standard rating scale score
  • People who have no more than minimal levels of depression, as measured by a standard depression rating scale for schizophrenia
  • People whose diagnosis falls into one of these categories (as confirmed by a structured clinical interview): attenuated psychosis syndrome, psychosis not otherwise specified, schizophreniform disorder, schizophrenia, or schizoaffective disorder

Who may not be able to join:

  • People who have a significant medical or neurological condition alongside their psychiatric diagnosis
  • People who have had a significant head injury
  • People whose intellectual functioning (IQ) is below 80 (though people with an IQ between 75 and 79 may still be considered if reading ability testing suggests their prior functioning was higher — confirm with trial site)
  • People assessed as being at high risk of suicide, based on a standard suicide risk rating scale
  • People who are pregnant, or who are not willing to avoid becoming pregnant during the trial
  • People who require treatment with any of the following medications: Azelastine, Azelastine with Fluticasone, Dronabinol, Valproic Acid, or Divalproex Sodium

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 26 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: Kristin Cadenhead, MD, University of California, San Diego

Phone: 619-543-6445

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
Registry
ClinicalTrials.gov
Start date
1 June 2022
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Positive and Negative Symptoms of Psychosis; Neurocognition; Prodromal Symptoms; General Symptoms; Clinical Global Impression Scale (CGI-S)

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: 26 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