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Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder (SERENITY II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04276883
Recruitment Status : Completed
First Posted : February 19, 2020
Last Update Posted : August 19, 2020
Cognitive Research Corporation
Information provided by (Responsible Party):
BioXcel Therapeutics Inc

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 efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.

Condition or disease Intervention/treatment Phase
Agitation Associated With Bipolar Disorder Agitation,Psychomotor Bipolar Disorder Drug: Sublingual film containing Dexmedetomidine (BXCL501) Drug: Placebo Film Phase 3

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 associated with bipolar disorder will be enrolled. Eligible subjects (acutely agitated subjects with bipolar disorder, generally hypomanic, manic or mixed episodes) may be identified in outpatient clinics, mental health, psychiatric or medical emergency services including medical/psychiatric observation units, or as newly admitted to a hospital setting for acute agitation or already in hospital for chronic underlying conditions. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: phase III, randomized, double-blind, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind, placebo-controlled
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine Efficacy and Safety of BXCL501 In Agitation Associated With Bipolar Disorder
Actual Study Start Date : February 24, 2020
Actual Primary Completion Date : May 21, 2020
Actual Study Completion Date : May 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: 120 Micrograms
Sublingual film containing 120 Micrograms Dexmedetomidine
Drug: Sublingual film containing Dexmedetomidine (BXCL501)
Sublingual film containing Dexmedetomidine (BXCL501)

Experimental: 180 Micrograms
Sublingual film containing 180 Micrograms Dexmedetomidine
Drug: Sublingual film containing Dexmedetomidine (BXCL501)
Sublingual film containing Dexmedetomidine (BXCL501)

Placebo Comparator: Placebo
Sublingual placebo film
Drug: Placebo Film
Placebo Film for BXCL501

Primary Outcome Measures :
  1. Primary End Point [ Time Frame: 120 minutes ]
    Absolute change from baseline in the PEC score at 2 hours

Secondary Outcome Measures :
  1. Key Secondary Endpoint [ Time Frame: 120 minutes ]
    Earliest time where an effect on agitation is apparent as measured by change from baseline PEC total score in contrast with placebo

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female patients between the ages of 18 to 75 years, inclusive.
  2. Patients who have met DSM-5 criteria for bipolar I or II disorder.
  3. 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).
  4. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
  5. Patients who read, understand and provide written informed consent.
  6. 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.
  7. Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria:

  1. 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.
  2. Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
  3. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
  4. Patients who are judged to be at significant risk of suicide.
  5. Female patients who have a positive pregnancy test at screening or are breastfeeding.
  6. 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.
  7. History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
  8. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.
  9. Patients with serious or unstable medical illnesses.
  10. Patients who have received an investigational drug within 30 days prior to the current agitation episode.
  11. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04276883

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United States, Arkansas
BioXcel Clinical Research Site
Little Rock, Arkansas, United States, 72211
United States, California
BioXcel Clinical Research Site
Cerritos, California, United States, 90703
BioXcel Clinical Research Site
Culver City, California, United States, 90230
BioXcel Clinical Research Site
Long Beach, California, United States, 90806
BioXcel Clinical Research Site
Orange, California, United States, 92868
United States, Florida
BioXcel Clinical Research Site
Miami Lakes, Florida, United States, 33016
United States, Illinois
BioXcel Clinical Research Site
Chicago, Illinois, United States, 60640
United States, Maryland
BioXcel Clinical Research Site
Gaithersburg, Maryland, United States, 20877
United States, Nevada
BioXcel Clinical Research Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
BioXcel Clinical Research Site
Berlin, New Jersey, United States, 08009
BioXcel Clinical Research Site
Marlton, New Jersey, United States, 08053
United States, South Carolina
BioXcel Clinical Research Site
Charleston, South Carolina, United States, 29407
United States, Texas
BioXcel Clinical Research Site
Austin, Texas, United States, 78754
BioXcel Clinical Research Site
DeSoto, Texas, United States, 75115
BioXcel Clinical Research Site
Richardson, Texas, United States, 75080
Sponsors and Collaborators
BioXcel Therapeutics Inc
Cognitive Research Corporation
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: BioXcel Therapeutics Inc Identifier: NCT04276883    
Other Study ID Numbers: BXCL501-302
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychomotor Agitation
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mood Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action