Dexmedetomidine for Agitation in Schizophrenia and Bipolar Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Verified Trial
Recruiting
Sponsor: BioXcel Therapeutics Inc
Must be taking: Psychotropic treatment
Must not be taking: Alpha blockers, Adrenergic agonists
Disqualifiers: Serious medical illnesses, Personality disorders, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
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.
What data supports the effectiveness of the drug Dexmedetomidine for treating agitation in schizophrenia and bipolar disorder?
Research shows that sublingual dexmedetomidine is effective in reducing agitation in adults with schizophrenia and bipolar disorder, as demonstrated in two phase 3 trials where it significantly improved symptoms compared to a placebo without causing serious side effects.
12345Is sublingual dexmedetomidine safe for treating agitation in schizophrenia and bipolar disorder?
Sublingual dexmedetomidine has been shown to be safe for treating acute agitation in adults with schizophrenia or bipolar disorder, with the most common side effect being mild drowsiness. Clinical trials reported no serious adverse events.
12345What makes the drug Dexmedetomidine unique for treating agitation in schizophrenia and bipolar disorder?
Dexmedetomidine is unique because it is administered as a sublingual film (placed under the tongue), which is non-invasive compared to the common intramuscular injections used for agitation. It works by targeting specific receptors in the brain (alpha-2 adrenergic receptors) and has been shown to be effective without causing serious side effects, making it a novel option for managing acute agitation in these conditions.
12345Eligibility Criteria
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
Do you often get upset or feel agitated?
Exclusion Criteria
Have you been diagnosed with Parkinson's Disease?
Have you been diagnosed with Meningitis?
Have you been diagnosed with Concussion?
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Part 1
One-day, in-clinic treatment of 60 mcg dose and post-treatment observation for acute agitation
1 day
1 visit (in-clinic)
Treatment Part 2
12-week study to determine the safety of a 120 mcg dose used as needed for agitation at home
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing BXCL501 against a placebo for reducing agitation in patients with bipolar disorder or schizophrenia-related conditions. Participants are randomly assigned to receive either the study drug or a placebo to compare effectiveness.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: 120 mcg of BXCL501Experimental Treatment1 Intervention
Sublingual film containing 120 Micrograms Dexmedetomidine
Group II: Part 1: 60 mcg of BXCL501Experimental Treatment1 Intervention
Sublingual film containing 60 Micrograms Dexmedetomidine
Group III: Part 2: Matching PlaceboPlacebo Group1 Intervention
Sublingual Placebo film
Group IV: Part 1: Matching PlaceboPlacebo Group1 Intervention
Sublingual Placebo film
BXCL501 is already approved in United States for the following indications:
🇺🇸 Approved in United States as IGALMI for:
- Agitation associated with schizophrenia or bipolar I or II disorder in adults
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Red Bird ResearchLas Vegas, NV
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Who Is Running the Clinical Trial?
BioXcel Therapeutics IncLead Sponsor
Worldwide Clinical TrialsCollaborator
References
Sublingual Dexmedetomidine for the Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder. [2023]Acute agitation is common amongst individuals with bipolar disorder and schizophrenia and represents a medical emergency. Commonly used medications for agitation, such as benzodiazepines and antipsychotics, are often delivered intramuscularly and may cause adverse effects. Non-invasive, effective, and safe alternative treatment options are needed. The purpose of this review article is to describe the efficacy and safety of sublingual formulation of dexmedetomidine (Igalmi), a selective α2-adrenergic receptor agonist, U.S. Food and Drug Administration approved for the treatment of acute agitation in adults with schizophrenia or bipolar I and II disorder. In two phase 3 trials, two dose strengths of sublingual dexmedetomidine 180 μg and 120 μg were safe and effective in managing acute agitation in patients with bipolar disorder or schizophrenia. Both doses significantly reduced Positive and Negative Syndrome Scale-Exited Component scores two hours after receiving a single dose as compared to placebo, indicating a substantial improvement in agitation. The beneficial effects of sublingual dexmedetomidine were achieved without serious adverse events with the most common side effect being mild somnolence. The clinical trial data suggest that sublingual dexmedetomidine represents a safe and effective treatment option in the armamentarium for acute agitation for people with schizophrenia or bipolar disorder.
Sublingual Dexmedetomidine for Agitation Associated with Schizophrenia or Bipolar Disorder: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed. [2023]The objective was to use the evidence-based medicine metrics of number needed to treat, number needed to harm, and likelihood to be helped or harmed to appraise the clinical efficacy and tolerability of sublingual dexmedetomidine in adults with agitation associated with schizophrenia or bipolar disorder.
Sublingual dexmedetomidine: repurposing an anesthetic as an anti-agitation agent. [2023]Especially when acutely ill, individuals with schizophrenia and bipolar disorder can present with agitated behavior. The initial approach to agitation management are non-pharmacologic strategies such as verbal de-escalation techniques; however, pharmacologic interventions may be needed. Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist, and a sublingual formulation has been approved in the US for the treatment of agitation associated with schizophrenia and bipolar disorder in adults.
The treatment of acute agitation associated with schizophrenia or bipolar disorder: investigational drugs in early stages of their clinical development, and their clinical context and potential place in therapy. [2020]Introduction: Acute agitation in patients with schizophrenia or bipolar disorder may require pharmacologic management. Ideal medication characteristics for this indication include rapid onset, minimal side effects, and noninvasive administration techniques.Areas Covered: This review summarizes investigational agents in early clinical development for the management of acute agitation in patients with psychosis or mania; it also assesses where these agents may fit with current therapies to provide a clinical perspective. The authors conducted a broad search of clinicaltrials.gov to identify investigational agents for agitation or aggression in patients with schizophrenia or bipolar disorder. Two medications met the search criteria: dexmedetomidine film (BXCL501) and intranasal olanzapine (INP105).Expert Opinion: Olanzapine is a well-known molecular entity in the psychiatric armamentarium but dexmedetomidine would be a new and unfamiliar agent for mental health providers. Nonetheless, although it is too early to make definitive statements about tolerability and efficacy, their unique administration mechanisms suggest that dexmedetomidine film and intranasal olanzapine may become valuable options for the rapid management of acute agitation in patients who are willing to cooperate with medication therapy.
Dexmedetomidine Sublingual Film: A New Treatment to Reduce Agitation in Schizophrenia and Bipolar Disorders. [2023]The objective of this study was to review the available literature for dexmedetomidine sublingual film use in the treatment of acute agitation associated with schizophrenia and bipolar disorders.