BXCL501 for Schizophrenia Agitation (DEX Trial)

Phase 2

Recruiting

Led By Mohini Ranganathan, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female between 18 and 65 years of age, inclusive

According to DSM-V meet criteria for Schizophrenia or Schizoaffective disorder.

Must not have

Women who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed prior to dosing, throughout study drug administration, and up to one week after drug administration

Summary

This trial is testing whether the drug Dexmedetomidine can help manage episodes of agitation among patients with schizophrenia.

Who is the study for?

This trial is for adults aged 18-65 with schizophrenia or schizoaffective disorder, who can give informed consent. It's not for those with substance dependence, pregnant or breastfeeding women, or individuals with significant medical conditions.

What is being tested?

The study tests sublingual Dexmedetomidine Hydrochloride to manage agitation in schizophrenia patients. A placebo group is included for comparison. The goal is to find the best dose range and assess how well patients tolerate it.

What are the potential side effects?

Dexmedetomidine may cause side effects such as dry mouth, low blood pressure, slow heart rate, dizziness upon standing up quickly and potential sedation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

I have been diagnosed with Schizophrenia or Schizoaffective disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours) for reporting.