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

• Status: Recruiting
• Trial end date: 2024-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioXcel Therapeutics Inc
• Collaborator: Worldwide Clinical Trials
• Treatments: Dexmedetomidine

Criteria

A patient may enroll in only one part of the study; either Part 1 or Part 2.

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 one clinical presentation of agitation requiring an intervention in the past month

• The patient has an Informant who can read, understand, and provide written informed consent and understand and follow the study procedures

Exclusion Criteria:

• Patients with serious or unstable medical illnesses.

• 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 in either a clinical trial or via prescription

• 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.