BXCL501 for Agitation in Schizophrenia (DEX)

April 17, 2023 updated by: Yale University

Safety and Efficacy of BXCL501, a Sublingual Film Delivery of Dexmedetomidine for the Treatment of Acute Agitation in Schizophrenia

Agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. While agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation, especially during exacerbation of disease, and clinicians do not always diagnose these episodes early enough. Agitation associated with psychosis is a frequent reason for emergency department visits, and unless it is recognized early and managed effectively, it can rapidly escalate to potentially dangerous behaviors, including physical violence. Educating psychiatric professionals about the timely and accurate diagnosis of agitation among patients with schizophrenia or bipolar disorder and developing a well-tolerated easily administered medication will contribute to the prompt and effective management of this condition and could help reduce the risk of violent behavior and other undesirable outcomes. This study is designed to identify the ideal dose range and tolerability of sublingual Dexmedetomidine in patients with schizophrenia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Connecticut Mental Health Center
        • Principal Investigator:
          • Mohini Ranganathan, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ability to give informed consent.
  2. Male or female between 18 and 65 years of age, inclusive
  3. According to DSM-V meet criteria for Schizophrenia or Schizoaffective disorder.

Exclusion Criteria:

  1. Current significant medical condition or other comorbidities
  2. Current substance dependence
  3. Women who are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Order 1
Subjects will be given a sublingual formulation of BXCL501 (dexmedetomidine)
Drug: Dexmedetomidine Hydrochloride
Dexmedetomidine Hydrochloride
Other Names:
  • Precedex
Placebo Comparator: Order 2
Subjects will be given a sublingual film of placebo.
Drug: Placebos
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Symptom Scale Excited Component (PANSS-EC)
Time Frame: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
PANSS-EC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored from 1 (minimum) to 7 (maximum). The PANSS-EC is the sum of these 5 subscales and ranges from 5 to 35.
Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
Skin conductance response (SCR)
Time Frame: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
SCR is one of the fastest-responding measures of stress response and arousal. Along with changes in heart rate, it has been found to be one of the most robust and non-invasive physiological measures of autonomic nervous system activity.
Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
Heart rate variability
Time Frame: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
Heart rate variability (HRV) is a measure of the variability in time intervals between heart beats and is sensitive to sympathetic activity as well as worsening of psychosis/agitation.
Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
Blood pressure
Time Frame: Measured at screening, prior to administartion, approximately every 15 minutes post drug administration, and one day after drug administration
Systolic and diastolic blood pressure
Measured at screening, prior to administartion, approximately every 15 minutes post drug administration, and one day after drug administration
Agitation-Calmness Scale (ACES)
Time Frame: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Designed to assess the clinical levels of calmness and sedation. This is a 9-point scale that differentiates between agitation, calmness, and sleep states Scores range from 1 (marked agitation)-9 (unarousable).
Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Richmond Agitation Sedation Scale (RASS)
Time Frame: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
The RASS is a 10-level rating scale ranging from "Combative" (+4) to "unarousable" (-5).
Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral Activity Rating Scale (BARS)
Time Frame: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Ranging from 1 to 7 where: 1 = difficult or unable to rouse, 2 = asleep but responds normally to verbal or physical contact, 3 = drowsy, appears sedated, 4 = quiet, and awake (normal level of activity), 5 = signs of overt (physical or verbal) activity, calms down with instructions, 6 = extremely or continuously active, not requiring restraint, 7 = violent, requires restraint.
Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Clinical Global Impressions-Improvement Scale (CGI-I)
Time Frame: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
Adverse Effects
Time Frame: Assessed prior to dosing, throughout study drug administration, and up to one week after drug administration
To determine any adverse effects on blood pressure, heart rate, or respiratory drive occurs before or coincident with the achievement of the aforementioned level of sedation.
Assessed prior to dosing, throughout study drug administration, and up to one week after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

October 12, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000023998

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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