Medication for agitation in schizophrenia
Safety and Efficacy of BXCL501, a Sublingual Film Delivery of Dexmedetomidine for the Treatment of Acute Agitation in Schizophrenia
This study is testing a new medication to see if it can help people with schizophrenia manage their agitation better and improve their overall care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT03708315 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Dexmedetomidine Hydrochloride to manage agitation in patients diagnosed with schizophrenia or schizoaffective disorder. The study aims to educate psychiatric professionals on the timely diagnosis of agitation and to develop a medication that is well-tolerated and easy to administer. By addressing agitation effectively, the trial seeks to reduce the risk of violent behavior and improve overall patient management during acute episodes. Participants will be monitored for their response to the medication compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been diagnosed with schizophrenia or schizoaffective disorder.
Not a fit: Patients with significant medical conditions, substance dependence, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of agitation in patients with schizophrenia, leading to better outcomes and reduced emergency interventions.
How similar studies have performed: Other studies have explored similar approaches to managing agitation in psychiatric conditions, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut
- Connecticut Mental Health Center — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Mohini Ranganathan, MD — Yale University
- Study coordinator: Carly Hewes, BS
- Email: carly.hewes@yale.edu
- Phone: 2039325711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.