Trial · NCT04819776

Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

NCT04819776, Phase 3, Completed, Vanda Pharmaceuticals; results first posted 2024-04-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder. Trials, record NCT04819776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04819776

On this page

Trial

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

Title: Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
NCT number: NCT04819776
Status: Completed
Phases: Phase 3
Enrollment: 417 participants, actual
Lead sponsor: Vanda Pharmaceuticals
Conditions: Bipolar I Disorder
Interventions: Iloperidone, Iloperidone Placebo
First posted: 2021-03-29
Last updated: 2024-04-18
Results first posted: 2024-04-16

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score	Week 4	The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score	Week 4	Efficacy analyses were based on the Intent-To-Treat (ITT) population, which included all randomized patients who received a dose of study drug and had at least one valid post-baseline efficacy measurement while on study medication. Of the 417 randomized, 392 received at least one dose of study medication and had at least one valid post-baseline efficacy measurement.	Change from Baseline in YMRS Total Score	MEAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score	Iloperidone		-14.0	Standard Error 0.64	Change from Baseline in YMRS Total Score
Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score	Placebo		-10.0	Standard Error 0.63	Change from Baseline in YMRS Total Score

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Iloperidone	206
Overall Study	STARTED	Placebo	208
Overall Study	COMPLETED	Iloperidone	139
Overall Study	COMPLETED	Placebo	153
Overall Study	NOT COMPLETED	Iloperidone	67
Overall Study	NOT COMPLETED	Placebo	55

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	Tachycardia	Cardiac disorders	Iloperidone	36	206
other	Tachycardia	Cardiac disorders	Placebo	11	208
other	Dizziness	Nervous system disorders	Iloperidone	23	206
other	Dizziness	Nervous system disorders	Placebo	2	208
other	Dry mouth	Gastrointestinal disorders	Iloperidone	19	206
other	Dry mouth	Gastrointestinal disorders	Placebo	4	208
other	Alanine aminotransferase increased	Investigations	Iloperidone	15	206
other	Alanine aminotransferase increased	Investigations	Placebo	1	208
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	Iloperidone	13	206
other	Nasal congestion	Respiratory, thoracic and mediastinal disorders	Placebo	3	208

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Iloperidone	0	206
Total, all-cause mortality	Placebo	0	208
Total, other adverse events	Iloperidone	88	206
Total, other adverse events	Placebo	25	208
Total, serious adverse events	Iloperidone	4	206
Total, serious adverse events	Placebo	1	208

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38236020	DERIVED

Source 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 comparisons2

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

Comparison	Source
Iloperidone vs Placebo: deaths from any cause	Trial comparisons
Iloperidone vs Placebo: serious adverse events	Trial comparisons

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/NCT04819776

GET https://conductscience.org/api/trials/v1/NCT04819776/events?page=2

API reference For AI assistants