Status:
COMPLETED
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
Lead Sponsor:
BioXcel Therapeutics Inc
Collaborating Sponsors:
Cognitive Research Corporation
Conditions:
Agitation Associated With Bipolar Disorder
Agitation,Psychomotor
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the effi...
Detailed Description
The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo stratified by age \< 65 and age ≥ 65. Male and female adults with acute agitation...
Eligibility Criteria
Inclusion
- Male and female patients between the ages of 18 to 75 years, inclusive.
- Patients who have met DSM-5 criteria for bipolar I or II disorder.
- 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 PANSS Excited Component (PEC).
- Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
- Patients who read, understand and provide written informed consent.
- Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
- Participants who agree to use a medically acceptable and effective birth control method
Exclusion
- Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
- Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
- Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
- Patients who are judged to be at significant risk of suicide.
- Female patients who have a positive pregnancy test at screening or are breastfeeding.
- Patients who have 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, orthostatic hypotension.
- Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
- Patients with serious or unstable medical illnesses.
- Patients who have received an investigational drug within 30 days prior to the current agitation episode.
- Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2020
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT04276883
Start Date
February 24 2020
End Date
May 21 2020
Last Update
September 11 2023
Active Locations (15)
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1
BioXcel Clinical Research Site
Little Rock, Arkansas, United States, 72211
2
BioXcel Clinical Research Site
Cerritos, California, United States, 90703
3
BioXcel Clinical Research Site
Culver City, California, United States, 90230
4
BioXcel Clinical Research Site
Long Beach, California, United States, 90806