Phase 1 Schizophrenia Trial, Recruiting NCT05025605 Sponsor: BioXcel Therapeutics Inc Condition: Schizophrenia
Back to Schizophrenia

Phase 1 Schizophrenia Trial, Recruiting

NCT05025605
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:

  • 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.

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 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: 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

Status
Recruiting
Phase
Phase 1
Sponsor
BioXcel Therapeutics Inc
Registry
ClinicalTrials.gov
Start date
27 August 2021
Est. completion
31 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total 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: 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