BXCL501 for Agitation in Schizophrenia (DEX)

Yale University

Status and phase: Completed; Phase 1

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Placebos; Drug: Dexmedetomidine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03708315

2000023998

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups, including a placebo group

Order 1

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine Hydrochloride

Order 2

Placebo Comparator group

Description:

Subjects will be given a sublingual film of placebo.

Treatment:

Drug: Placebos