Clinical trial NCT03708315: BXCL501 for Agitation in Schizophrenia
Official title: Safety and Efficacy of BXCL501, a Sublingual Film Delivery of Dexmedetomidine for the Treatment of Acute Agitation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The subjects will be randomized and will get either a sublingual formulation of dexmedetomidine or placebo.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Positive and Negative Symptom Scale Excited Component (PANSS-EC)
timeFrame: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
measure: Skin conductance response (SCR)
timeFrame: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
measure: Heart rate variability
timeFrame: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
measure: Blood pressure
timeFrame: Measured at screening, prior to administartion, approximately every 15 minutes post drug administration, and one day after drug administration
measure: Agitation-Calmness Scale (ACES)
timeFrame: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
measure: Richmond Agitation Sedation Scale (RASS)
timeFrame: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Secondary outcomes:
measure: Behavioral Activity Rating Scale (BARS)
timeFrame: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
measure: Clinical Global Impressions-Improvement Scale (CGI-I)
timeFrame: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
measure: Adverse Effects
timeFrame: Assessed prior to dosing, throughout study drug administration, and up to one week after drug administration
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Mohini Ranganathan, MD
role: PRINCIPAL_INVESTIGATOR
References: