Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder

• Status: Completed
• Trial end date: 2024-04-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioXcel Therapeutics Inc
• Collaborator: Lotus Clinical Research, LLC
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

1. Male and female subjects between the ages of 18 to 65 years, inclusive.

2. Subjects who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder or bipolar I or II disorder.

3. Subjects who are currently moderate to severely agitated at least 3 days a week.

4. Subjects who read, understand, and provide written informed consent.

5. 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.

6. Subjects who agree to use a medically acceptable and effective birth control method

7. Subjects must be willing to remain in-clinic for the duration of the study.

Exclusion Criteria:

1. Subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse during screening.

2. Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before study treatment.

3. Subjects with congenital prolonged QT syndrome.

4. Prior treatment with Igalmi