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Phase II

BXCL501 for Agitation in Schizophrenia (DEX)

  • Study HIC#:2000023998
  • Last Updated:01/18/2024

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.

  • Age18 years - 65 years
  • GenderBoth

Contact Us

For more information about this study, including how to volunteer, contact:

Lia Urban Spillane

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Trial Purpose and Description

Primary Outcome Measures:

1) PANSS-EC Change from Baseline [ Time Frame: 2 hours] The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC is the sum of these 5 subscales and ranges from 5 to 35.

2) The optimal intravenous dose of dexmedetomidine in schizophrenia patients in terms of efficacy and safety in order to achieve arousable sedation (Richmond Agitation Scale Score of -2) that can be temporarily reversed by verbal stimulation.

Eligibility Criteria

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

Principal Investigator


For more information about this study, including how to volunteer, contact: