Trial · NCT00132314

Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

NCT00132314, Phase 3, Completed, US Department of Veterans Affairs; results first posted 2013-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-Acting Injectable Risperidone in the Treatment of Schizophrenia. Trials, record NCT00132314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00132314

On this page

Trial

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

Title: Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
NCT number: NCT00132314
Status: Completed
Phases: Phase 3
Enrollment: 382 participants, actual
Lead sponsor: US Department of Veterans Affairs
Conditions: Schizoaffective Disorder, Schizophrenia
Interventions: IM risperidone, oral antipsychotic medication
First posted: 2005-08-19
Last updated: 2013-12-20
Results first posted: 2013-12-20

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Hospitalization-free Survival - Time to Event	From randomization until date of first re-hospitalization, assessed up to 24 months	A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization. Patients without an event were censored at 24 months after the date of randomization.
Primary	Hazard Ratio for Hospitalization	24 months	Hazard ratio of LAI versus Oral for psychiatric hospitalization (in both VA and non-VA hospitals), after randomization up to 24 months, obtained from a Cox proportional hazards model.

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	Hospitalization-free Survival - Time to Event	From randomization until date of first re-hospitalization, assessed up to 24 months		years	MEDIAN
PRIMARY	Hazard Ratio for Hospitalization	24 months		participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Spread	Units
Hospitalization-free Survival - Time to Event	Injectable Risperidone		NA	95% Confidence Interval 1.84 to NA	years
Hospitalization-free Survival - Time to Event	Oral Antipsychotic		1.97	95% Confidence Interval 1.19 to NA	years
Hazard Ratio for Hospitalization	Injectable Risperidone	Patients with psychiatric hospitalization	72		participants
Hazard Ratio for Hospitalization	Oral Antipsychotic	Patients with psychiatric hospitalization	81		participants
Hazard Ratio for Hospitalization	Injectable Risperidone	Patients without psychiatric hospitalization	115		participants
Hazard Ratio for Hospitalization	Oral Antipsychotic	Patients without psychiatric hospitalization	101		participants

Source ClinicalTrials.gov

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Injectable Risperidone	190
Overall Study	STARTED	Oral Antipsychotic	192
Overall Study	Received Treatment	Injectable Risperidone	188
Overall Study	Received Treatment	Oral Antipsychotic	185
Overall Study	Completed Baseline Visit, Provided SSN	Injectable Risperidone	187
Overall Study	Completed Baseline Visit, Provided SSN	Oral Antipsychotic	182
Overall Study	COMPLETED	Injectable Risperidone	117
Overall Study	COMPLETED	Oral Antipsychotic	120
Overall Study	NOT COMPLETED	Injectable Risperidone	73
Overall Study	NOT COMPLETED	Oral Antipsychotic	72

Source ClinicalTrials.gov

Adverse events182

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	Events
other	Vertigo	Ear and labyrinth disorders	Injectable Risperidone	21	187	26
other	Vertigo	Ear and labyrinth disorders	Oral Antipsychotic	22	182	28
other	Vision blurred	Eye disorders	Injectable Risperidone	10	187	10
other	Vision blurred	Eye disorders	Oral Antipsychotic	12	182	14
other	Constipation	Gastrointestinal disorders	Injectable Risperidone	22	187	33
other	Constipation	Gastrointestinal disorders	Oral Antipsychotic	20	182	25
other	Diarrhoea	Gastrointestinal disorders	Injectable Risperidone	14	187	15
other	Diarrhoea	Gastrointestinal disorders	Oral Antipsychotic	13	182	15
other	Dry mouth	Gastrointestinal disorders	Injectable Risperidone	21	187	34
other	Dry mouth	Gastrointestinal disorders	Oral Antipsychotic	22	182	29

1 to 10 of 182Source ClinicalTrials.gov

See all 182 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Injectable Risperidone
Total, all-cause mortality	Oral Antipsychotic
Total, other adverse events	Injectable Risperidone	132	187
Total, other adverse events	Oral Antipsychotic	123	182
Total, serious adverse events	Injectable Risperidone	96	187
Total, serious adverse events	Oral Antipsychotic	91	182

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21270143	RESULT	PubMed
21366475	RESULT	PubMed
21514794	RESULT	PubMed
22697193	RESULT	PubMed
23143523	DERIVED	PubMed
23473656	RESULT	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 comparisons1

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

Comparison
Injectable Risperidone vs Oral Antipsychotic: serious adverse events

Source 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/NCT00132314

GET https://conductscience.org/api/trials/v1/NCT00132314/events?page=2

API reference For AI assistants