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Alpha-2 Adrenergic Agonist

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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

DEX Trial 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.Check my eligibility

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.See study design

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.

DEX Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I have been diagnosed with Schizophrenia or Schizoaffective disorder.

DEX Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Agitation-Calmness Scale (ACES)

Blood pressure

Heart rate variability

+3 more

Secondary outcome measures

Adverse Effects

Behavioral Activity Rating Scale (BARS)

Clinical Global Impressions-Improvement Scale (CGI-I)

DEX Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Order 1Active Control1 Intervention

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

Group II: Order 2Placebo Group1 Intervention

Subjects will be given a sublingual film of placebo.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,163 Total Patients Enrolled

59 Trials studying Schizophrenia

3,969 Patients Enrolled for Schizophrenia

Mohini Ranganathan, MDPrincipal InvestigatorYale University

4 Previous Clinical Trials

59 Total Patients Enrolled

1 Trials studying Schizophrenia

21 Patients Enrolled for Schizophrenia

Media Library

Dexmedetomidine Hydrochloride (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03708315 — Phase 2

Schizophrenia Research Study Groups: Order 1, Order 2

Schizophrenia Clinical Trial 2023: Dexmedetomidine Hydrochloride Highlights & Side Effects. Trial Name: NCT03708315 — Phase 2

Dexmedetomidine Hydrochloride (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03708315 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who are the ideal candidates for this clinical trial?

"This psychiatric study is seeking around 50 individuals who have been diagnosed with schizophrenia and are between 18-65 years old."

Answered by AI

Does this research include adults aged 45 and up?

"This study only allows patients that fall within a certain age range, being over 18 years old and younger than 65."

Answered by AI

What condition is Order 1 typically employed against?

"Order 1 can be used to treat various diseases, including but not limited to ventilations, mechanical, and cyclic vomiting syndrome."

Answered by AI

Is Order 1 a common medication studied in clinical trials?

"At this moment, there are 119 ongoing studies concerning Order 1 with 25 of them in Phase 3. The majority of research concerning Order 1 is being conducted in Karachi, Sindh; however, there are 221 total locations running studies for Order 1."

Answered by AI

Are researchers still able to enroll new participants in this trial?

"From the information available on clinicaltrials.gov, it appears that this clinical trial is still recruiting patients. This study was first posted on March 9th, 2020, and was edited on July 22nd, 2022. They are looking for 50 patients total from 1 site."

Answered by AI

What level of risk is associated with Order 1 for human users?

"Order 1's safety was evaluated as a 2. This is because, while there is data supporting safety, there is no information suggesting that Order 1 is an effective medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BXCL501 for Agitation in Schizophrenia

2020. "BXCL501 for Agitation in Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03708315.

All > Schizophrenia