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Igalmi for Agitation in Schizophrenia/Bipolar Disorder

Phase 4
Recruiting
Research Sponsored by BioXcel Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8 through day 10
Awards & highlights

Study Summary

This trial will look at how an anti-agitation drug affects people with schizophrenia or bipolar disorder over time.

Who is the study for?
Adults aged 18-65 with schizophrenia or bipolar disorder experiencing moderate to severe agitation at least three times a week can join. They must be in good health, agree to use effective birth control, and stay in-clinic for the study duration. Those with drug-induced agitation, recent benzodiazepine or antipsychotic use, congenital prolonged QT syndrome, or prior Igalmi treatment cannot participate.Check my eligibility
What is being tested?
The trial is testing how patients respond over time to repeated doses of a sublingual film containing Igalmi when they have agitation related to schizophrenia or bipolar disorder. It's an open-label study where everyone gets the same treatment and stays in the clinic.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to taking Igalmi repeatedly. Side effects could range from mild discomfort at the administration site to more significant systemic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I or II.
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I experience severe agitation at least 3 days a week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8 through day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 through day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Clinical Global Impression - Improvement (CGI-I)
Secondary outcome measures
Incidence of Adverse Events During the Follow-up Period

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active Treatment - 180 mcg of Igalmi (dexmedetomidine)Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

BioXcel Therapeutics IncLead Sponsor
19 Previous Clinical Trials
2,412 Total Patients Enrolled
Lotus Clinical Research, LLCOTHER
14 Previous Clinical Trials
1,745 Total Patients Enrolled
Robert Risinger, MDStudy ChairBioXcel Therapeutics
10 Previous Clinical Trials
1,802 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must individuals meet to be considered for enrollment in this medical experiment?

"To be eligible for this clinical trial, participants must have schizophrenia and fall between 18-65 years old. Our team is aiming to recruit a group of 20 individuals in total."

Answered by AI

Is the utilization of Active Treatment - 180 mcg of Igalmi (dexmedetomidine) accepted by the FDA?

"This advanced medical treatment has undergone multiple clinical trials and is approved for use, so it scored a 3 on our rudimentary safety scale."

Answered by AI

Do individuals below the age of 35 fulfill the prerequisites for this experiment?

"The age limit for this trial is 18 to 65; if you are younger or older than that, there still may be medical trials available - 126 studies cater towards minors and 372 clinical investigations accept elderly participants."

Answered by AI

What is the highest amount of participants in this research project?

"Affirmative. Clinicaltrials.gov data suggests that this research study is presently signing up participants, which commenced on September 1st 2023 and was most recently edited on the 21st of the same month. The trial requires enrollment from 20 individuals across 2 centres."

Answered by AI

Is recruitment for this clinical experiment currently open?

"Affirmative. Clinicaltrials.gov provides evidence that this study is actively seeking volunteers, with the initial posting dated September 1st 2023 and most recent update occurring on September 21st 2023. The experiment requires a total of 20 test subjects across two separate research sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
2023. "Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041646.
~13 spots leftby Apr 2025
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