BXCL501 for Agitation in Schizophrenia

Phase 2

Recruiting

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Drug: Dexmedetomidine Hydrochloride; Drug: Placebos

• Registration Number: NCT03708315
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-17
• Study Start: 2020-03-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Order 1	Dexmedetomidine Hydrochloride	Subjects will be given a sublingual formulation of BXCL501 (dexmedetomidine)
Order 2	Placebos	Subjects will be given a sublingual film of placebo.

Primary Outcome Measures

Name	Time	Method
Blood pressure	Measured at screening, prior to administartion, approximately every 15 minutes post drug administration, and one day after drug administration	Systolic and diastolic blood pressure
Agitation-Calmness Scale (ACES)	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).
Positive and Negative Symptom Scale Excited Component (PANSS-EC)	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.
Skin conductance response (SCR)	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.
Heart rate variability	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.
Richmond Agitation Sedation Scale (RASS)	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 Outcome Measures

Name	Time	Method
Behavioral Activity Rating Scale (BARS)	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.
Clinical Global Impressions-Improvement Scale (CGI-I)	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.
Adverse Effects	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.

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States