Trial · NCT04276883

Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

NCT04276883, Phase 3, Completed, BioXcel Therapeutics Inc; results first posted 2023-09-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder. Trials, record NCT04276883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04276883

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
NCT number: NCT04276883
Status: Completed
Phases: Phase 3
Enrollment: 380 participants, actual
Lead sponsor: BioXcel Therapeutics Inc
Conditions: Agitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
Interventions: Sublingual film containing Dexmedetomidine (BXCL501), Placebo Film
First posted: 2020-02-19
Last updated: 2026-08-11
Results first posted: 2023-09-11

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	Baseline and 120 minutes	The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).
Secondary	Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	Baseline and 20, 30, 45, 60, 90, 120 minutes post-dose	Effect on agitation onset was measured by change from baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) total score. The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items -poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	Baseline and 120 minutes	Intent-to-Treat population, defined as all participants in the safety population who have a PEC score post-dose.	score on a scale	MEAN
SECONDARY	Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	Baseline and 20, 30, 45, 60, 90, 120 minutes post-dose	Intent-to-Treat population, defined as all participants in the safety population who have a PEC score post-dose.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	180 Micrograms	Baseline	18.0	Standard Deviation 2.99	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	120 Micrograms	Baseline	18.0	Standard Deviation 2.73	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	Placebo	Baseline	17.9	Standard Deviation 2.94	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	180 Micrograms	Change from Baseline at 120 Minutes	-10.4	Standard Deviation 4.45	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	120 Micrograms	Change from Baseline at 120 Minutes	-9.0	Standard Deviation 5.26	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	Placebo	Change from Baseline at 120 Minutes	-4.9	Standard Deviation 4.67	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	180 Micrograms	Baseline	18	Standard Deviation 2.99	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	120 Micrograms	Baseline	18	Standard Deviation 2.73	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	Placebo	Baseline	17.9	Standard Deviation 2.94	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	180 Micrograms	Change from Baseline at 20 minutes	-3.1	Standard Deviation 4.45	score on a scale

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	180 Micrograms	127
Overall Study	STARTED	120 Micrograms	127
Overall Study	STARTED	Placebo	126
Overall Study	COMPLETED	180 Micrograms	123
Overall Study	COMPLETED	120 Micrograms	119
Overall Study	COMPLETED	Placebo	120
Overall Study	NOT COMPLETED	180 Micrograms	4
Overall Study	NOT COMPLETED	120 Micrograms	8
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events27

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Somnolence	Nervous system disorders	180 Micrograms	27	126
other	Somnolence	Nervous system disorders	120 Micrograms	26	126
other	Somnolence	Nervous system disorders	Placebo	6	126
other	Dizziness	Nervous system disorders	180 Micrograms	7	126
other	Dizziness	Nervous system disorders	120 Micrograms	7	126
other	Dizziness	Nervous system disorders	Placebo	1	126
other	Headache	Nervous system disorders	180 Micrograms	2	126
other	Headache	Nervous system disorders	120 Micrograms	6	126
other	Headache	Nervous system disorders	Placebo	6	126
other	Dry mouth	Gastrointestinal disorders	180 Micrograms	6	126

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	180 Micrograms	0	126
Total, all-cause mortality	120 Micrograms	0	126
Total, all-cause mortality	Placebo	0	126
Total, other adverse events	180 Micrograms	45	126
Total, other adverse events	120 Micrograms	44	126
Total, other adverse events	Placebo	19	126
Total, serious adverse events	180 Micrograms	0	126
Total, serious adverse events	120 Micrograms	1	126
Total, serious adverse events	Placebo	0	126

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35191924	DERIVED	PubMed
36002761	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04276883

GET https://conductscience.org/api/trials/v1/NCT04276883/results?page=2

API reference For AI assistants