ER agitation study pulled before it began
NCT ID NCT05974527
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if a dissolvable film placed under the tongue could quickly calm agitation in people with bipolar disorder or schizophrenia who come to the emergency room. The drug, BXCL501, is already approved for this use, but the study wanted to test it in the ER setting. However, the study was withdrawn before any participants were enrolled.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Expected to start
-
Sep 2023
An estimate. Start dates often move.
- Expected to finish
-
Jun 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * English speaking adults age ≥18 years * Patients with an established diagnosis of (1) bipolar I disorder, (2) bipolar II disorder, (3) schizophrenia, (4) schizoaffective disorder, or (5) schizophreniform disorder * Judged to be clinically agitated at the time of Screening and Baseline with a AMSS ≥2 * Able to read, understand, and provide written informed consent * Subject judged to be likely capable of self-administration of BXCL501 sublingually or buccally Exclusion Criteria: * Likely to be discharged, admitted, or transferred from the ED within 6 hours after study medication administration * Administration of benzodiazepines or antipsychotic drugs in the 2 hours before study treatment * Treatment with alpha-1 noradrenergic antagonists * Female patients who are pregnant or are breastfeeding * Hypotension (systolic blood pressure \<100 mmHg or diastolic blood pressure \<60 mmHg) and/or bradycardia (heart rate \<55 beats per minute) at the time of Screening or Baseline evaluation * History of dysautonomia * Patient with a known diagnosis of familial long QT syndrome, second degree or third degree atrioventricular block without pacemaker, or sick sinus syndrome * Patients with serious or unstable medical illnesses determined by the study investigators or qualified designees * Patients with history of allergic reactions to dexmedetomidine * Patients previously enrolled and completed the current study * Patients actively enrolled in other ED-based studies involving pharmacological or behavioral interventions
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Agitation are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Five sessions to quiet trauma nightmares in bipolar disorder
- Scientists probe brain's reward system in mental illness
- New schizophrenia drug targets brain glutamate, not dopamine
- New drug candidate takes aim at schizophrenia symptoms
- New schizophrenia drug goes Head-to-Head with standard antipsychotics in Long-Term trial
- Five-Year safety check for experimental schizophrenia drug