Precedex for Schizophrenia
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/19/2018 |
| Start Date: | November 2019 |
| End Date: | May 2021 |
| Contact: | Harsimar Kaur, MBBS |
| Email: | Harsimar.Kaur@yale.edu |
| Phone: | 2039747544 |
Safety and Efficacy of Intravenous Dexmedetomidine in the Treatment of 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 I.V Dexmedetomidine as a prelude to testing a sublingual formulation for
efficacy in patients with schizophrenia.
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 I.V Dexmedetomidine as a prelude to testing a sublingual formulation for
efficacy in patients with schizophrenia.
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 Spectrum and other Psychotic
disorders.
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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