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NCT03708315 · ClinicalTrials.gov registry record · Phase 1
BXCL501 for Agitation in Schizophrenia
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03708315 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 11 participants.
The verdict
NCT03708315, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebos
- DRUG Dexmedetomidine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-03-09 |
| Est. Completion | 2023-05-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03708315
The ClinicalTrials.gov registry entry for NCT03708315 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03708315 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03708315 about?
NCT03708315 is a clinical study titled "BXCL501 for Agitation in 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 ...
What is the current status of trial NCT03708315?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2020-03-09. Estimated completion is 2023-05-26.
What interventions are being tested in trial NCT03708315?
The interventions under investigation include: Placebos (DRUG), Dexmedetomidine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03708315?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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