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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05658510

Public ClinicalTrials.gov record NCT05658510. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 12:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05658510
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
BioXcel Therapeutics Inc
Industry
Enrollment
452 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 21, 2022 (Actual)
Primary completion
Aug 15, 2025 (Actual)
Completion
Aug 15, 2025 (Actual)
Last update posted
Aug 7, 2026

2022 – 2025

United States locations

U.S. sites
24
U.S. states
10
U.S. cities
22
Facility City State ZIP Site status
BioXcel Clinical Research Site 113 Bellflower California 90706 —
BioXcel Clinical Research Site 128 Cerritos California 90703 —
BioXcel Clinical Research Site 110 Culver City California 90230 —
BioXcel Clinical Research Site 108 Garden Grove California 92845 —
BioXcel Clinical Research Site 117 Lemon Grove California 91945 —
BioXcel Clinical Research Site 121 Los Angeles California 90015 —
BioXcel Clinical Research Site 123 Oceanside California 92056 —
BioXcel Clinical Research Site 104 Orange California 92868 —
BioXcel Clinical Research Site 133 Rancho Cucamonga California 91730 —
BioXcel Clinical Research Site 114 Riverside California 92506 —
BioXcel Clinical Research Site 129 Denver Colorado 80209 —
BioXcel Clinical Research Site 131 Miami Florida 33122 —
BioXcel Clinical Research Site 124 Miami Florida 33186 —
BioXcel Clinical Research Site 130 Elgin Illinois 60123 —
BioXcel Clinical Research Site 103 Gaithersburg Maryland 20877 —
BioXcel Clinical Research Site 118 Las Vegas Nevada 89102 —
BioXcel Clinical Research Site 137 Las Vegas Nevada 89119 —
BioXcel Clinical Research Site 105 Berlin New Jersey 08009 —
BioXcel Clinical Research Site 122 Beachwood Ohio 44122 —
BioXcel Clinical Research Site 136 Austin Texas 78754 —
BioXcel Clinical Research Site 102 DeSoto Texas 75115 —
BioXcel Clinical Research Site 125 Irving Texas 75062 —
BioXcel Clinical Research Site 127 Plano Texas 75093 —
BioXcel Clinical Research Site 126 Everett Washington 98201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05658510, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 7, 2026 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05658510 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →