Phase 1 Schizophrenia Trial, Recruiting
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:
- Young people aged 10–17 years old who have been diagnosed with bipolar disorder, or aged 13–17 years old who have been diagnosed with schizophrenia.
- Patients who are showing signs of significant agitation (restlessness or emotional distress), as measured by a specific rating scale score of 14 or higher at the time of screening and at the start of the study.
- Patients who score 4 or higher on at least one part of that same agitation rating scale at the start of the study.
- Participants who agree to use an effective and medically accepted form of birth control during the trial.
Who may not be able to join:
- Patients whose agitation appears to be caused by being under the influence of alcohol or drugs (with the exception of cannabis/THC), as shown by a urine test.
- Patients who have taken certain calming or antipsychotic medications (such as benzodiazepines or short-acting injected antipsychotics) within the 4 hours before receiving the study treatment.
- Patients who are considered to be at serious risk of harming themselves or attempting suicide.
- Patients who have a serious or unstable physical health condition.
- Patients who have taken part in another clinical trial and received an experimental drug within the 30 days before their current episode of agitation.
- Patients who the study doctor feels, for any reason, are not a good fit for receiving the study drug (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.
Contact this trial
Principal Investigator: Robert Risinger, MD, BioXcel Therapeutics
Phone: 475-238-6837
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
Where this trial is recruiting
Primary endpoints
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
Can't join this trial?
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.