Status:
COMPLETED
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
Lead Sponsor:
BioXcel Therapeutics Inc
Collaborating Sponsors:
Lotus Clinical Research, LLC
Conditions:
Bipolar Disorder
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 schiz...
Detailed Description
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 (18 to 65 years old, inclusive) with...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06041646
Start Date
October 2 2023
End Date
April 29 2024
Last Update
January 2 2026
Active Locations (2)
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1
BioXcel Clinical Research Site
Little Rock, Arkansas, United States, 72211
2
BioXcel Clinical Research Site
Rogers, Arkansas, United States, 72758