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Dexmedetomidine for Agitation in Schizophrenia and Bipolar Disorder
Study Summary
This trial tests an investigational medication for treating episodes of agitation in bipolar I/II, schizophrenia, schizoaffective and schizophreniform disorder. It compares the drug to a placebo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 798 Patients • NCT02004613Trial Design
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- I've been on a steady treatment for my condition for the last 3 months.I've needed help for agitation 3 times in the last 3 months.I use medication as needed to manage sudden agitation episodes.I have a history of fainting or currently have low blood volume or blood pressure issues when standing.I have been diagnosed with bipolar disorder, schizophrenia, or a related condition.You are not showing signs of being very agitated due to being drunk or using drugs, except for THC.I am not taking medications like terazosin, doxazosin, or similar drugs.I haven't taken any sedatives or antipsychotic drugs in the 4 hours before the study treatment.My overall health is good as confirmed by various medical tests.I needed help for agitation in the last month.I haven't taken any sedatives or antipsychotic drugs in the 4 hours before treatment.I am between 18 and 75 years old.I am between 18 and 75 years old.You have a high score on a specific test called the PEC at the beginning of the study.I have previously taken IGALMI™ or participated in a trial for BXCL501.You were diagnosed with certain personality disorders before being diagnosed with schizophrenia or bipolar disorder.You are considered to be very agitated based on a set of questions about your behavior and emotions.I am not pregnant or breastfeeding.I have been diagnosed with bipolar disorder, schizophrenia, or a related condition.I have a history of serious brain or neurological conditions.I do not have any serious or unstable illnesses.You are considered to be at high risk of harming yourself.You have a history of getting very upset because of using drugs or alcohol.You have abnormal test results that are important to your doctor.You have already participated in a clinical trial involving BXCL501 (Part 1 only).You are not currently showing aggressive behavior due to being intoxicated with alcohol or drugs, except for THC.
- Group 1: Part 2: 80 mcg of BXCL501
- Group 2: Part 1: Matching Placebo
- Group 3: Part 1: 60 mcg of BXCL501
- Group 4: Part 2: Matching Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is eligibility for this clinical trial restricted to individuals over 50 years of age?
"As outlined by the ineligibility parameters, the minimum age requirement to participate is 18 years old, while those aged 75 or older are excluded."
Are individuals currently able to enrol in this research project?
"Based on clinicaltrials.gov, this trial is currently in search of participants with an initial posting date set at November 21st 2022 and a recent update made on December 12th 2021."
Has the Food and Drug Administration given authorization to use 60 mcg of BXCL501 in Part 1?
"The safety assessment of 60 mcg BXCL501 has been rated a 3 due to the evidence collected in Phase 3 trials, including data that positively supports its efficacy and multiple rounds verifying its security."
To what extent is enrollment in this clinical trial being expanded?
"Affirmative. Clinicaltrials.gov records demonstrate that this medical experiment, going live on November 21st 2022, is still recruiting participants. 450 people are needed to join the trial at two different sites."
Am I eligible to be a part of this experiment?
"This trial is seeking 450 participants who have akathisia, aged between 18 and 75. Additional criteria must be met, such as being able to read and understand written informed consent and having a minimum score of 14 on the Poor Impulse Control Scale (PEC). Additionally, those enrolled in Part 1 require effective birth control use while those enrolling in Part 2 need to meet Diagnostic & Statistical Manual 5/5-Text Revision requirements for bipolar I or II disorder, schizophrenia, schizoaffective or schizophreniform disorders. Furthermore all potential patients are subject to a comprehensive medical history review alongside physical examination, 12-lead ECG testing"
What is the objective of this clinical experiment?
"According to the study sponsor, BioXcel Therapeutics Inc., their primary outcome is Part 2: Occurrence of treatment-emergent adverse events (TEAEs) over a two hour period. Additionally, they will be measuring secondary outcomes such as Part 1: Shift in Modified Clinical Global Impression - Severity (mCGI-S) scores from baseline, Part 1: Number of responders based on mCGI-S score, and Part1: Change from Baseline in Agitation-Calmness Evaluation Scale (ACES)."
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