Trial · NCT04268303

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

NCT04268303, Phase 3, Completed, BioXcel Therapeutics Inc; results first posted 2023-06-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia. Trials, record NCT04268303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04268303

On this page

Trial

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

Title: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
NCT number: NCT04268303
Status: Completed
Phases: Phase 3
Enrollment: 380 participants, actual
Lead sponsor: BioXcel Therapeutics Inc
Conditions: Agitation, Schizophrenia, Schizo Affective Disorder, Schizoaffective Disorder, Schizophreniform Disorders
Interventions: Sublingual film containing dexmedetomidine (BXCL501), Placebo Film
First posted: 2020-02-13
Last updated: 2026-08-11
Results first posted: 2023-06-18

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 2 hours	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 10, 20, 30, 45, 60, 90 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 2 hours	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 10, 20, 30, 45, 60, 90 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	120 Micrograms	Baseline	17.5	Standard Deviation 2.46	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	180 Micrograms	Baseline	17.6	Standard Deviation 2.69	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	Placebo	Baseline	17.6	Standard Deviation 2.26	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	120 Micrograms	2 Hours	-8.4	Standard Deviation 4.83	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	180 Micrograms	2 Hours	-10.4	Standard Deviation 4.34	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score	Placebo	2 Hours	-4.7	Standard Deviation 4.69	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	120 Micrograms	Baseline	17.5	Standard Deviation 2.46	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	180 Micrograms	Baseline	17.6	Standard Deviation 2.69	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	Placebo	Baseline	17.6	Standard Deviation 2.26	score on a scale
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time	120 Micrograms	10 minutes	-1.3	Standard Deviation 2.50	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	120 Micrograms	129
Overall Study	STARTED	180 Micrograms	125
Overall Study	STARTED	Placebo	126
Overall Study	COMPLETED	120 Micrograms	126
Overall Study	COMPLETED	180 Micrograms	123
Overall Study	COMPLETED	Placebo	123
Overall Study	NOT COMPLETED	120 Micrograms	3
Overall Study	NOT COMPLETED	180 Micrograms	2
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events24

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	Dizziness	Nervous system disorders	120 Micrograms	3	129
other	Dizziness	Nervous system disorders	180 Micrograms	8	126
other	Dizziness	Nervous system disorders	Placebo	1	126
other	Dry mouth	Gastrointestinal disorders	120 Micrograms	10	129
other	Dry mouth	Gastrointestinal disorders	180 Micrograms	5	126
other	Dry mouth	Gastrointestinal disorders	Placebo	2	126
other	Headache	Nervous system disorders	120 Micrograms	6	129
other	Headache	Nervous system disorders	180 Micrograms	4	126
other	Headache	Nervous system disorders	Placebo	6	126
other	Hypoesthesia oral	Nervous system disorders	120 Micrograms	5	129

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	120 Micrograms	0	129
Total, all-cause mortality	180 Micrograms	0	126
Total, all-cause mortality	Placebo	0	126
Total, other adverse events	120 Micrograms	51	129
Total, other adverse events	180 Micrograms	47	126
Total, other adverse events	Placebo	19	126
Total, serious adverse events	120 Micrograms	0	129
Total, serious adverse events	180 Micrograms	0	126
Total, serious adverse events	Placebo	0	126

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36002761	DERIVED	PubMed
36198061	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/NCT04268303

GET https://conductscience.org/api/trials/v1/NCT04268303/results?page=2

API reference For AI assistants