Dexmedetomidine for Agitation in Schizophrenia and Bipolar Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medication, BXCL501 (also known as Dexmedetomidine), to evaluate its effectiveness in reducing agitation in individuals with mental health conditions such as bipolar disorder and schizophrenia. The study compares the medication's effects to a placebo, which contains no active ingredients. Individuals who have experienced agitation episodes requiring medical attention or have stable treatment for their condition may be suitable candidates. Participants join only one part of the study, which involves taking a sublingual film (dissolves under the tongue) containing either the medication or a placebo. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that patients in Part 2 stay on their current stable psychotropic treatment for the duration of the study. However, patients currently treated with certain medications like alpha-1 noradrenergic blockers or alpha-2 adrenergic agonists cannot participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that BXCL501 is well-tolerated by patients. Research indicates that patients using BXCL501 at home for episodes of agitation did not experience significant side effects, suggesting the treatment is generally safe. Additionally, BXCL501 is a form of dexmedetomidine, already approved by the FDA for other uses, which provides some confidence about its safety. While no treatment is without risk, existing evidence supports the safety of BXCL501 in managing agitation.12345
Why do researchers think this study treatment might be promising for agitation in schizophrenia and bipolar disorder?
Most treatments for agitation in schizophrenia and bipolar disorder, like antipsychotics and benzodiazepines, primarily target dopamine or GABA receptors to calm the nervous system. But BXCL501 works differently; it's a sublingual film containing dexmedetomidine, which acts on alpha-2 adrenergic receptors to reduce agitation. This novel mechanism offers a potentially quicker onset of action and fewer sedative side effects compared to traditional options. Researchers are particularly excited about its ease of use, as the sublingual film allows for simple administration without the need for injections or pills, making it a convenient option for those in need of immediate relief.
What evidence suggests that BXCL501 could be an effective treatment for agitation in schizophrenia and bipolar disorder?
Research has shown that BXCL501, a form of the drug dexmedetomidine, can greatly reduce feelings of agitation. Earlier studies found it significantly lessened agitation symptoms compared to a placebo, with noticeable effects starting just two hours after administration. In this trial, participants will receive either 60 mcg or 120 mcg of BXCL501, or a matching placebo, to evaluate its effectiveness in treating agitation in people with bipolar disorder and schizophrenia. The treatment comes as a small film placed under the tongue, which helps it work quickly. Early results indicate it can safely and effectively reduce episodes of agitation.13467
Who Is on the Research Team?
Matt Mandel, MD
Principal Investigator
BioXcel Therapeutics
Are You a Good Fit for This Trial?
Adults aged 18-75 with bipolar I or II, schizophrenia, schizoaffective, or schizophreniform disorder who've had recent agitation episodes may join. They must be in good health based on medical exams and agree to use birth control. Exclusions include certain mental disorders pre-dating their diagnosis, recent investigational drug use, specific medication treatments, pregnancy/breastfeeding women, and those with serious neurological conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
One-day, in-clinic treatment of 60 mcg dose and post-treatment observation for acute agitation
Treatment Part 2
12-week study to determine the safety of a 120 mcg dose used as needed for agitation at home
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BXCL501
- Matching Placebo
BXCL501 is already approved in United States for the following indications:
- Agitation associated with schizophrenia or bipolar I or II disorder in adults
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioXcel Therapeutics Inc
Lead Sponsor
Worldwide Clinical Trials
Collaborator