NCT06041646CompletedPhase 4
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
Characterization of Tachyphylaxis, Tolerance, and Withdrawal After Discontinuation of Igalmi in Frequently Agitated Schizophrenic or Bipolar Patients After 7 Days of PRN Treatment
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 11 Sept 2023
- Start date
- 2 Oct 2023
- Primary completion date
- 29 Apr 2024
- Lead sponsor
- BioXcel Therapeutics Inc
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT06041646
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 29
- From 2 Oct 2023 to the primary completion date, 29 Apr 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse during screening.
- Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before study treatment.
- Prior treatment with Igalmi
Lab values
- Subjects with congenital prolonged QT syndrome.
Who the study is looking for
- Male and female subjects between the ages of 18 to 65 years, inclusive.
- Subjects who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder or bipolar I or II disorder.
- Subjects who are currently moderate to severely agitated at least 3 days a week.
- Subjects who read, understand, and provide written informed consent.
- Subjects who are in good general health prior to study participation as determined by a detailed medical history and in the opinion of the Principal Investigator.
- Subjects who agree to use a medically acceptable and effective birth control method
- Subjects must be willing to remain in-clinic for the duration of the study.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Rogers | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.