Loading clinical trials...

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT05658510•BioXcel Therapeutics Inc

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a randomized, double-blind, placebo-controlled, 2-Part, Phase III study to assess the efficacy, safety, and tolerability of BXCL501 in adult (18-75 years old) males and females with agitation episodes associated with a primary diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder. Part 1 of the study is a one-day, in-clinic treatment of 60 mcg dose, and post-treatment observation period with patients experiencing an acute episode of agitation. Part 1 is now complete. Part 2 of the study is a 12-week study to determine the safety of a BXCL501 120 mcg dose when used as needed for episodes of agitation at home.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A patient may enroll in only one part of the study; either Part 1 or Part 2.
•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
•Part 1 only
•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.
•Part 2 only
+4 more criteria

Exclusion Criteria

•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
+15 more criteria

Locations (24)

BioXcel Clinical Research Site 113

Bellflower, California, United States

BioXcel Clinical Research Site 128

Cerritos, California, United States

BioXcel Clinical Research Site 110

Culver City, California, United States

BioXcel Clinical Research Site 108

Garden Grove, California, United States

BioXcel Clinical Research Site 117

Lemon Grove, California, United States

BioXcel Clinical Research Site 121

Los Angeles, California, United States

BioXcel Clinical Research Site 123

Oceanside, California, United States

BioXcel Clinical Research Site 104

Orange, California, United States

BioXcel Clinical Research Site 133

Rancho Cucamonga, California, United States

BioXcel Clinical Research Site 114

Riverside, California, United States

Key Dates

Start Date

November 21, 2022

Primary Completion Date

August 15, 2025

Completion Date

August 15, 2025

Last Updated

September 18, 2025

Enrollment

452

ACTUAL participants

Conditions

Agitation,PsychomotorBipolar I DisorderBipolar II DisorderSchizophreniaSchizoaffective DisorderSchizophreniform Disorders

Interventions

BXCL501

DRUG

Matching Placebo

DRUG

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

NCT06184581

Bipolar II Disorder

View study

RECRUITINGPHASE3

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

NCT05303064

SchizophreniaBipolar I Disorder

View study

RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Lithium Versus Lamotrigine in Bipolar Disorder, Type II

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder

Sequential Multiple Assignment Randomized Trial for Bipolar Depression