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

NCT ID: NCT05658510

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2025-08-15

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1: 60 mcg of BXCL501

Sublingual film containing 60 Micrograms Dexmedetomidine

Group Type: EXPERIMENTAL

BXCL501

Intervention Type: DRUG

Sublingual Film

Part 1: Matching Placebo

Sublingual Placebo film

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

Sublingual Placebo Film

Part 2: 120 mcg of BXCL501

Sublingual film containing 120 Micrograms Dexmedetomidine

Group Type: EXPERIMENTAL

BXCL501

Intervention Type: DRUG

Sublingual Film

Part 2: Matching Placebo

Sublingual Placebo film

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

Sublingual Placebo Film

Interventions

BXCL501

Sublingual Film

Intervention Type: DRUG

Matching Placebo

Sublingual Placebo Film

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine; Placebo

Eligibility Criteria

Inclusion 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

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

• 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.

• At least 18 years of age at the time of screening.

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
• 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.

Part 1 only

• 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.

Part 2 only

• 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.

• Has known the patient for at least 3 months cumulatively.
• Currently living with or routinely contacting the patient at least five days a week.
• Does not plan to discontinue contact with the patient during the study period.
• Willing and able to provide written informed consent.
• Willing and able to follow the study procedures, including completing the Agitation Episode Diary and other study procedures during the study.
• Willing and able to accompany patient and remain present at the clinical site during the clinic visits and be interviewed by the Investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Worldwide Clinical Trials

OTHER

Sponsor Role: collaborator

BioXcel Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matt Mandel, MD

Role: STUDY_CHAIR

BioXcel Therapeutics

Locations

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

BioXcel Clinical Research Site 129

Denver, Colorado, United States

BioXcel Clinical Research Site 131

Miami, Florida, United States

BioXcel Clinical Research Site 124

Miami, Florida, United States

BioXcel Clinical Research Site 130

Elgin, Illinois, United States

BioXcel Clinical Research Site 103

Gaithersburg, Maryland, United States

BioXcel Clinical Research Site 118

Las Vegas, Nevada, United States

BioXcel Clinical Research Site 137

Las Vegas, Nevada, United States

BioXcel Clinical Research Site 105

Berlin, New Jersey, United States

BioXcel Clinical Research Site 122

Beachwood, Ohio, United States

BioXcel Clinical Research Site 136

Austin, Texas, United States

BioXcel Clinical Research Site 102

DeSoto, Texas, United States

BioXcel Clinical Research Site 125

Irving, Texas, United States

BioXcel Clinical Research Site 127

Plano, Texas, United States

BioXcel Clinical Research Site 126

Everett, Washington, United States

Countries

United States

Other Identifiers

BXCL501-401

Identifier Type: -

Identifier Source: org_study_id