Phase 4
N=29
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
Bipolar Disorder · Schizophrenia · Agitation,Psychomotor · Schizo Affective Disorder · Schizophreniform Disorders
Bottom Line
View on ClinicalTrials.gov: NCT06041646 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score — -10.4; -10.0; -10.1; -9.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sublingual film containing Igalmi (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioXcel Therapeutics Inc
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score |
-10.4; -10.0; -10.1; -9.8; -11.5; -8.7 | — |
| PRIMARY Clinical Global Impression - Improvement (CGI-I) |
1.2; 1.2; 1.3; 1.0; 1.2; 1.3 | — |
| SECONDARY Number of Participants With Adverse Events During the Follow-up Period |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT06041646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.