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NCT05658510 · ClinicalTrials.gov registry record · Phase 3

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

A Phase 3 study, sponsored by BioXcel Therapeutics.

Completed
Registry status
Phase 3
Development phase
452
Enrollment target

NCT05658510 is a Phase 3 study that has completed, run by BioXcel Therapeutics. The registered enrollment target is 452 participants.

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The verdict

NCT05658510, a Phase 3 study, has completed, sponsored by BioXcel Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
452 participants
Enrollment target

Study Summary

In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.

Interventions

  • DRUG Matching Placebo
  • DRUG BXCL501

Trial Details

FieldValue
Enrollment Target 452 participants
Start Date 2022-11-21
Est. Completion 2025-08-15
Phase Phase 3

Sponsor

BioXcel Therapeutics

13 total trials

What the Registry Record Tells You About NCT05658510

The ClinicalTrials.gov registry entry for NCT05658510 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 452 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioXcel Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.

NCT05658510 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05658510 about?

NCT05658510 is a clinical study titled "Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)". In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.

What is the current status of trial NCT05658510?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 452 participants. The study started on 2022-11-21. Estimated completion is 2025-08-15.

What interventions are being tested in trial NCT05658510?

The interventions under investigation include: Matching Placebo (DRUG), BXCL501 (DRUG).

Who is sponsoring clinical trial NCT05658510?

This trial is sponsored by BioXcel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.