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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

Tracking Information
First Submitted Date  ICMJE February 18, 2020
First Posted Date  ICMJE February 19, 2020
Last Update Posted Date August 19, 2020
Actual Study Start Date  ICMJE February 24, 2020
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
Primary End Point [ Time Frame: 120 minutes ]
Absolute change from baseline in the PEC score at 2 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
Official Title  ICMJE A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine Efficacy and Safety of BXCL501 In Agitation Associated With Bipolar Disorder
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Agitation Associated With Bipolar Disorder
  • Agitation,Psychomotor
  • Bipolar Disorder
Intervention  ICMJE
  • Drug: Sublingual film containing Dexmedetomidine (BXCL501)
    Sublingual film containing Dexmedetomidine (BXCL501)
  • Drug: Placebo Film
    Placebo Film for BXCL501
Study Arms  ICMJE
  • Experimental: 120 Micrograms
    Sublingual film containing 120 Micrograms Dexmedetomidine
    Intervention: Drug: Sublingual film containing Dexmedetomidine (BXCL501)
  • Experimental: 180 Micrograms
    Sublingual film containing 180 Micrograms Dexmedetomidine
    Intervention: Drug: Sublingual film containing Dexmedetomidine (BXCL501)
  • Placebo Comparator: Placebo
    Sublingual placebo film
    Intervention: Drug: Placebo Film
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2020)
Actual Study Completion Date  ICMJE May 21, 2020
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04276883
Other Study ID Numbers  ICMJE BXCL501-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioXcel Therapeutics Inc
Study Sponsor  ICMJE BioXcel Therapeutics Inc
Collaborators  ICMJE Cognitive Research Corporation
Investigators  ICMJE Not Provided
PRS Account BioXcel Therapeutics Inc
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP