Trial · NCT00254202

Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

NCT00254202, Phase 3, Completed, Vanda Pharmaceuticals; results first posted 2024-12-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia. Trials, record NCT00254202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00254202

On this page

Trial

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

Title: Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
NCT number: NCT00254202
Status: Completed
Phases: Phase 3
Enrollment: 593 participants, actual
Lead sponsor: Vanda Pharmaceuticals
Conditions: Schizophrenia
Interventions: Iloperidone, Ziprasidone, Placebo
First posted: 2005-11-15
Last updated: 2026-10-06
Results first posted: 2024-12-13

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 in Positive and Negative Symptom Scale Total (PANSS-T) Score	4 weeks	The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.

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 in Positive and Negative Symptom Scale Total (PANSS-T) Score	4 weeks	The modified Intent-to-Treat (ITT) population comprise all randomized patients who receive at least one dose of study medication in the short-term double-blind phase and for whom a baseline PANSS score measurement is obtained and at least one post-baseline PANSS score measurement is obtained while on study medication. For patients randomized in error at a second site after being randomized once, the data from the second site were excluded from analysis in the modified ITT population.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score	Iloperidone	-12.0	Standard Error 1.03	score on a scale
Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score	Ziprasidone	-12.3	Standard Error 1.44	score on a scale
Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score	Placebo	-7.1	Standard Error 1.48	score on a scale

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Iloperidone	295
Overall Study	STARTED	Ziprasidone	149
Overall Study	STARTED	Placebo	149
Overall Study	Safety Population	Iloperidone	300
Overall Study	Safety Population	Ziprasidone	150
Overall Study	Safety Population	Placebo	147
Overall Study	COMPLETED	Iloperidone	193
Overall Study	COMPLETED	Ziprasidone	98
Overall Study	COMPLETED	Placebo	90
Overall Study	NOT COMPLETED	Iloperidone	102

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events99

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	Iloperidone	51	300
other	Dizziness	Nervous system disorders	Ziprasidone	20	150
other	Dizziness	Nervous system disorders	Placebo	11	147
other	Sedation	Nervous system disorders	Iloperidone	38	300
other	Sedation	Nervous system disorders	Ziprasidone	41	150
other	Sedation	Nervous system disorders	Placebo	12	147
other	Weight increased	Investigations	Iloperidone	34	300
other	Weight increased	Investigations	Ziprasidone	7	150
other	Weight increased	Investigations	Placebo	3	147
other	Dry mouth	Gastrointestinal disorders	Iloperidone	26	300

1 to 10 of 99Source ClinicalTrials.gov

See all 99 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Iloperidone	0	300
Total, all-cause mortality	Ziprasidone	0	150
Total, all-cause mortality	Placebo	0	147
Total, other adverse events	Iloperidone	221	300
Total, other adverse events	Ziprasidone	118	150
Total, other adverse events	Placebo	86	147
Total, serious adverse events	Iloperidone	2	300
Total, serious adverse events	Ziprasidone	2	150
Total, serious adverse events	Placebo	5	147

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18334909	BACKGROUND	PubMed
19573479	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/NCT00254202

GET https://conductscience.org/api/trials/v1/NCT00254202/events?page=2

API reference For AI assistants