Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
Completed · Phase 4
Conditions studied: Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder, Schizophreniform Disorders
In brief
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.
Key facts
- Study ID
- NCT06041646
- Run by
- BioXcel Therapeutics Inc
- People needed
- 29
- Starts
- 2023-10-02
- Expected to finish
- 2024-04-29
- Last updated by the study team
- 2026-01-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Subjects with congenital prolonged QT syndrome.
- Prior treatment with Igalmi
Where it is running
- BioXcel Clinical Research Site — Little Rock, Arkansas, United States
- BioXcel Clinical Research Site — Rogers, Arkansas, United States
Full record on ClinicalTrials.gov
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