BXCL501 for Agitation in Schizophrenia

NCT03708315 | Completed Phase 1 FDA Drug

• 1 other identifier: 2000023998
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (6)

• Positive and Negative Symptom Scale Excited Component (PANSS-EC)

  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)

  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

  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

  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)

  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)

  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 Outcomes (3)

• Behavioral Activity Rating Scale (BARS)

  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)

  Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.

• Adverse Effects

  Assessed prior to dosing, throughout study drug administration, and up to one week after drug administration

Study Arms (2)

Order 1

ACTIVE COMPARATOR

Subjects will be given a sublingual formulation of BXCL501 (dexmedetomidine)

Drug: Dexmedetomidine Hydrochloride

Order 2

PLACEBO COMPARATOR

Subjects will be given a sublingual film of placebo.

Drug: Placebos

Interventions

Dexmedetomidine Hydrochloride DRUG

Dexmedetomidine Hydrochloride

Also known as: Precedex

Order 1

Placebos DRUG

Placebo

Order 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current significant medical condition or other comorbidities
• Current substance dependence
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohini Ranganathan, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subjects will be randomized and will get either a sublingual formulation of dexmedetomidine or placebo.

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: March 9, 2020
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (1)