COMPLETED

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

Conditions

Agitation,Psychomotor Bipolar I Disorder Bipolar II Disorder Schizophrenia Schizoaffective Disorder Schizophreniform Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder

Quick Facts

Study Start:2022-11-21

Study Completion:2025-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05658510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male and female patients between the ages of 18 to 75 years, inclusive * Patients who can read, understand and provide written informed consent. * Patients who have met Diagnostic and Statistical Manual5/5-Text Revision criteria for bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder. * Patients who, in the opinion of the Principal Investigator, are in good general health before study participation based on a detailed medical history, a physical examination, a 12-lead ECG, a blood chemistry profile, hematology, and urinalysis. * Participants who agree to use a medically acceptable and effective birth control method * Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PEC. * Patients with a score of ≥4 on at least 1 of the 5 items on the PEC at Baseline. * Patients have had at least three clinical presentations of agitation requiring an intervention (e.g., receipt of as needed \[PRN\] medication for the episode, clinic visit, emergency room visit, emergency medical services intervention, law enforcement intervention) in the past three months prior to Screening * Patients who are receiving stable psychotropic treatment for 30 days prior to Screening for the underlying primary diagnosis and who are expected to remain on stable treatment for the duration of the study. * The patient can understand and follow the study procedures, including completing the Agitation Episode Diary.	* Patients with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, or hematologic disease. * A history of agitation episodes due to substance use. * A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder * Patients who are judged to be at significant risk of suicide * Female patients who have a positive pregnancy test at Screening or Baseline, or are breastfeeding. * Patients currently treated with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin), alpha-2 adrenergic agonists, or other prohibited medications. * Patients with hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease, or focal neurological findings. * History of syncope or other syncopal attacks, current evidence of hypovolemia, or orthostatic hypotension * Patients with laboratory or ECG abnormalities considered clinically significant by the Investigator * Patients who have received an investigational drug within 30 days before the study start * Patients who have previously received BXCL501 via prescription (under the trade name IGALMI™) or received BXCL501 in clinical trial * Patients considered by the Investigator to be unsuitable candidates for receiving dexmedetomidine or considered to be unsuitable for participating in the study for any reason. * Patients with agitation caused by acute intoxication, including identification of alcohol by breathalyzer or drugs of abuse (except for THC) during urine screening. * Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 4 hours before study treatment. * Psychiatric comorbidities are generally allowed; however, moderate or severe substance use disorders (SUD) (within the past 6 months) are exclusionary if the substance involved is other than nicotine or caffeine. Cannabis use is not exclusionary if it is not the focus of treatment in the last 6 months before Screening. * Self-injurious behavior that is active. * Patients with known personal or family history of genetic long QT syndrome.

Inclusion Criteria

Exclusion Criteria

* Male and female patients between the ages of 18 to 75 years, inclusive
* Patients who can read, understand and provide written informed consent.
* Patients who have met Diagnostic and Statistical Manual5/5-Text Revision criteria for bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.
* Patients who, in the opinion of the Principal Investigator, are in good general health before study participation based on a detailed medical history, a physical examination, a 12-lead ECG, a blood chemistry profile, hematology, and urinalysis.
* Participants who agree to use a medically acceptable and effective birth control method
* Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PEC.
* Patients with a score of ≥4 on at least 1 of the 5 items on the PEC at Baseline.
* Patients have had at least three clinical presentations of agitation requiring an intervention (e.g., receipt of as needed \[PRN\] medication for the episode, clinic visit, emergency room visit, emergency medical services intervention, law enforcement intervention) in the past three months prior to Screening
* Patients who are receiving stable psychotropic treatment for 30 days prior to Screening for the underlying primary diagnosis and who are expected to remain on stable treatment for the duration of the study.
* The patient can understand and follow the study procedures, including completing the Agitation Episode Diary.

* Patients with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, or hematologic disease.
* A history of agitation episodes due to substance use.
* A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder
* Patients who are judged to be at significant risk of suicide
* Female patients who have a positive pregnancy test at Screening or Baseline, or are breastfeeding.
* Patients currently treated with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin), alpha-2 adrenergic agonists, or other prohibited medications.
* Patients with hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease, or focal neurological findings.
* History of syncope or other syncopal attacks, current evidence of hypovolemia, or orthostatic hypotension
* Patients with laboratory or ECG abnormalities considered clinically significant by the Investigator
* Patients who have received an investigational drug within 30 days before the study start
* Patients who have previously received BXCL501 via prescription (under the trade name IGALMI™) or received BXCL501 in clinical trial
* Patients considered by the Investigator to be unsuitable candidates for receiving dexmedetomidine or considered to be unsuitable for participating in the study for any reason.
* Patients with agitation caused by acute intoxication, including identification of alcohol by breathalyzer or drugs of abuse (except for THC) during urine screening.
* Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 4 hours before study treatment.
* Psychiatric comorbidities are generally allowed; however, moderate or severe substance use disorders (SUD) (within the past 6 months) are exclusionary if the substance involved is other than nicotine or caffeine. Cannabis use is not exclusionary if it is not the focus of treatment in the last 6 months before Screening.
* Self-injurious behavior that is active.
* Patients with known personal or family history of genetic long QT syndrome.

Contacts and Locations

Principal Investigator

Matt Mandel, MD

STUDY_CHAIR

BioXcel Therapeutics

Study Locations (Sites)

BioXcel Clinical Research Site 113

Bellflower, California, 90706

United States

BioXcel Clinical Research Site 128

Cerritos, California, 90703

United States

BioXcel Clinical Research Site 110

Culver City, California, 90230

United States

BioXcel Clinical Research Site 108

Garden Grove, California, 92845

United States

BioXcel Clinical Research Site 117

Lemon Grove, California, 91945

United States

BioXcel Clinical Research Site 121

Los Angeles, California, 90015

United States

BioXcel Clinical Research Site 123

Oceanside, California, 92056

United States

BioXcel Clinical Research Site 104

Orange, California, 92868

United States

BioXcel Clinical Research Site 133

Rancho Cucamonga, California, 91730

United States

BioXcel Clinical Research Site 114

Riverside, California, 92506

United States

BioXcel Clinical Research Site 129

Denver, Colorado, 80209

United States

BioXcel Clinical Research Site 131

Miami, Florida, 33122

United States

BioXcel Clinical Research Site 124

Miami, Florida, 33186

United States

BioXcel Clinical Research Site 130

Elgin, Illinois, 60123

United States

BioXcel Clinical Research Site 103

Gaithersburg, Maryland, 20877

United States

BioXcel Clinical Research Site 118

Las Vegas, Nevada, 89102

United States

BioXcel Clinical Research Site 137

Las Vegas, Nevada, 89119

United States

BioXcel Clinical Research Site 105

Berlin, New Jersey, 08009

United States

BioXcel Clinical Research Site 122

Beachwood, Ohio, 44122

United States

BioXcel Clinical Research Site 136

Austin, Texas, 78754

United States

BioXcel Clinical Research Site 102

DeSoto, Texas, 75115

United States

BioXcel Clinical Research Site 125

Irving, Texas, 75062

United States

BioXcel Clinical Research Site 127

Plano, Texas, 75093

United States

BioXcel Clinical Research Site 126

Everett, Washington, 98201

United States

Collaborators and Investigators

Sponsor: BioXcel Therapeutics Inc

Matt Mandel, MD, STUDY_CHAIR, BioXcel Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-21

Study Completion Date2025-08-15

Study Record Updates

Study Start Date2022-11-21

Study Completion Date2025-08-15

Terms related to this study

Additional Relevant MeSH Terms

Agitation,Psychomotor
Bipolar I Disorder
Bipolar II Disorder
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders