CompletedPhase 4

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

United States29 participantsStarted 2023-10-02

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score

Timeframe: Baseline and 2 hours post-dose for all doses administered over 7 days.

Clinical Global Impression - Improvement (CGI-I)

Timeframe: 2 hours post-dose for all doses administered over 7 days.

Trial details

NCT IDNCT06041646

SponsorBioXcel Therapeutics Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-29

Results submitted2025-11-10

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