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OpenTrials
Completed

NCT Number: NCT03708315

BXCL501 for 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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Dexmedetomidine Hydrochloride

Drug

Dexmedetomidine Hydrochloride

Other names: Precedex

Placebos

Drug

Placebo

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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).

  6. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Acronym: DEX

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2018
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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