Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
Bipolar Disorder, Schizophrenia, Agitation,Psychomotor
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Agitation, Schizophrenia, Bipolar, Dexmedetomidine, tachyphylaxis, tolerance, withdrawal, PRN treatment, Open-Label, PEC, CGI, ACES, Safety, Tolerability, Igalmi
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- BioXcel Clinical Research SiteRecruiting
- BioXcel Clinical Research SiteRecruiting
Arms of the Study
Arm 1
Other
Active Treatment - 180 mcg of Igalmi (dexmedetomidine)
An initial dose of 180 µg of Igalmi as needed for the treatment of agitation over a period of 7 days. In the event of persistent or recurrent agitation, investigators may choose to repeat dose at 90 μg after the 2-hour time point in the absence of dose-limiting adverse events or safety concerns. A maximum of 2 repeat doses will be allowed in a 24-hour period.