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Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
Sponsor: BioXcel Therapeutics Inc
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.
Official title: Characterization of Tachyphylaxis, Tolerance, and Withdrawal After Discontinuation of Igalmi in Frequently Agitated Schizophrenic or Bipolar Patients After 7 Days of PRN Treatment
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2023-10-02
Completion Date
2024-04-29
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
Sublingual film containing Igalmi
Sublingual film containing 180 µg of Igalmi (dexmedetomidine)
Locations (2)
BioXcel Clinical Research Site
Little Rock, Arkansas, United States
BioXcel Clinical Research Site
Rogers, Arkansas, United States