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Dexmedetomidine vs Lorazepam for Agitation in Schizophrenia or Bipolar Disorder

Phase 4
Recruiting
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hospitalized on an inpatient unit at Episcopal Hospital
Meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, as determined by routine clinical assessment conducted upon admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 15, 30, 60, 90, and 120 minutes
Awards & highlights

Study Summary

This trial compares the effects of a drug (dexmedetomidine) to a known drug (lorazepam) in treating agitation in people with schizophrenia or bipolar disorder.

Who is the study for?
Adults aged 18-55 with schizophrenia, schizoaffective disorder, or bipolar disorder experiencing moderate to severe agitation can join. They must be inpatients at Episcopal Hospital, not allergic to the study drugs, and not on high-risk medications or have certain health conditions like severe liver issues or heart problems.Check my eligibility
What is being tested?
The trial is testing sublingual dexmedetomidine against lorazepam for calming patients with significant agitation due to mental health conditions. The effectiveness will be measured using specific scales that assess excitement and calmness levels.See study design
What are the potential side effects?
Dexmedetomidine may cause dry mouth, low blood pressure, slow heart rate, and drowsiness. Lorazepam can lead to sedation, weakness, low blood pressure as well but also has a risk of dependence with long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently admitted as an inpatient at Episcopal Hospital.
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I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.
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I am between 18 and 55 years old.
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I am experiencing a moderate to severe episode of agitation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 15, 30, 60, 90, and 120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 15, 30, 60, 90, and 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in PANSS-EC score at 120 minutes after medication administration
Secondary outcome measures
Assess the need for rescue medication for agitation within two hours of medication administration
Change from baseline in ACES score at 15, 30, 60, 90, and 120 minutes, or prior to receipt of any rescue medication for agitation.
Change in PANSS-EC score at 15, 30, 60, and 90 minutes, or prior to receipt of any rescue medication for agitation.
+2 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DexmedetomidineExperimental Treatment1 Intervention
Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed.
Group II: LorazapemActive Control1 Intervention
Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~1980

Find a Location

Who is running the clinical trial?

Temple UniversityLead Sponsor
297 Previous Clinical Trials
82,941 Total Patients Enrolled
1 Trials studying Bipolar Disorder
52 Patients Enrolled for Bipolar Disorder
BioXcel Therapeutics IncIndustry Sponsor
19 Previous Clinical Trials
2,400 Total Patients Enrolled
4 Trials studying Bipolar Disorder
990 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

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

What are the potential risks associated with using Dexmedetomidine?

"As this treatment has been approved, our team at Power assigned Dexmedetomidine a score of 3 for safety on the 1-3 scale."

Answered by AI

Is there an opportunity to join the research study?

"Candidates between 18 and 55 with a diagnosis of bipolar disorder can apply for this medical trial. A total of 32 participants are sought by the research team."

Answered by AI

Are there any opportunities for qualified individuals to partake in this research?

"The trial, posted to clinicaltrials.gov on July 1st 2023 and last amended on October 16th of that year, is actively seeking participants."

Answered by AI

Does this trial include participants aged 70 and above?

"To be eligible for this specific medical trial, the patient must be between 18 and 55 years old. Separately, there are 128 trials available to younger patients under 18 and 414 research studies targeting those older than 65."

Answered by AI

How many subjects have enrolled in this research project?

"Affirmative. Data hosted on clinicaltrials.gov stipulates that this research initiative, which was initially made public on July 1st 2023, is currently recruiting patients. 32 people need to be enrolled at one location."

Answered by AI

Who else is applying?

What site did they apply to?
Temple University Episcopal Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
Justin Faden 2023. "Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06093451.
All > Bipolar Disorder
~5 spots leftby Jul 2024
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