Trial · NCT00330863

Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy

NCT00330863, Phase 4, Completed, Northwell Health; results first posted 2018-07-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy. Trials, record NCT00330863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00330863

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Trial

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

Title: Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy
NCT number: NCT00330863
Status: Completed
Phases: Phase 4
Enrollment: 357 participants, actual
Lead sponsor: Northwell Health
Conditions: Schizophrenia, Schizoaffective Disorder
Interventions: Risperidone microspheres, Risperidone, Olanzapine, Quetiapine, Ziprasidone, Aripiprazole, Paliperidone
First posted: 2006-05-29
Last updated: 2018-07-10
Results first posted: 2018-07-10

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Substantial Clinical Deterioration Measured by Psychotic Symptoms	Measured throughout study up to 30 months	Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms.
Secondary	Number of Patients Discontinuing From the Study	Measured throughout study up to 30 months
Secondary	Number of Days in Hospital	Measured throughout study up to 30 months
Secondary	Control of Psychiatric Symptoms	Measured throughout study up to 30 months	Brief Psychiatric Rating Scale (BPRS) total score
Secondary	Quality of Life Measures	Measured throughout study up to 30 months	Scale of Functioning (SOF)
Secondary	Side Effects and Metabolic Measures	Measured throughout study up to 30 months	The highest severity of each of 24 adverse event (AE) that was assessed.over the 30 month study period. The mean severity on a scale of 1 (none) to 4 very severe symptom was recorded at each biweekly visit. Results for each variable are summarized over time so that each subject has a single mean severity rating for each AE. There is no named scale. Each of the side effects measured is named in ways that are clear to medical readers e.g anorexia. The range is 1 none to 4 very severe. Therefore, a higher scale score is worse.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Substantial Clinical Deterioration Measured by Psychotic Symptoms	Measured throughout study up to 30 months	We conducted a mixed model regression analysis with two treatment groups X time psychosis cluster scores at each 3 monthly observation from baseline to 30 months. Missing data were treated as MAR	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Patients Discontinuing From the Study	Measured throughout study up to 30 months		participants	NUMBER
SECONDARY	Number of Days in Hospital	Measured throughout study up to 30 months	These data were not collected.
SECONDARY	Control of Psychiatric Symptoms	Measured throughout study up to 30 months	These data were not collected. No data displayed because Outcome Measure has zero total participants analyzed.
SECONDARY	Quality of Life Measures	Measured throughout study up to 30 months	No data displayed because Outcome Measure has zero total participants analyzed. Data not collected.
SECONDARY	Side Effects and Metabolic Measures	Measured throughout study up to 30 months		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group52

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

Outcome	Group	Category	Value	Spread	Units
Substantial Clinical Deterioration Measured by Psychotic Symptoms	Injectable		1.8	95% Confidence Interval 1.7 to 1.9	units on a scale
Substantial Clinical Deterioration Measured by Psychotic Symptoms	Oral		2.0	95% Confidence Interval 1.9 to 2.2	units on a scale
Number of Patients Discontinuing From the Study	Injectable		81		participants
Number of Patients Discontinuing From the Study	Oral		80		participants
Side Effects and Metabolic Measures	Injectable	Bruising easily	1.43	Standard Deviation 0.71	units on a scale
Side Effects and Metabolic Measures	Oral	Bruising easily	1.48	Standard Deviation 0.75	units on a scale
Side Effects and Metabolic Measures	Injectable	Rash	1.53	Standard Deviation 0.78	units on a scale
Side Effects and Metabolic Measures	Oral	Rash	1.44	Standard Deviation 0.71	units on a scale
Side Effects and Metabolic Measures	Injectable	Urticaria (hives, itching)	1.60	Standard Deviation 0.69	units on a scale
Side Effects and Metabolic Measures	Oral	Urticaria (hives, itching)	1.71	Standard Deviation 0.84	units on a scale

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Injectable	153
Overall Study	STARTED	Oral	152
Overall Study	COMPLETED	Injectable	72
Overall Study	COMPLETED	Oral	72
Overall Study	NOT COMPLETED	Injectable	81
Overall Study	NOT COMPLETED	Oral	80

Source ClinicalTrials.gov

Adverse events4

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	anorexia	Psychiatric disorders	Injectable	143	143
other	anorexia	Psychiatric disorders	Oral	148	148
serious	first relapse often hospitalization	Psychiatric disorders	Injectable	61	146
serious	first relapse often hospitalization	Psychiatric disorders	Oral	48	150

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Injectable
Total, all-cause mortality	Oral
Total, other adverse events	Injectable	143	143
Total, other adverse events	Oral	148	148
Total, serious adverse events	Injectable	61	146
Total, serious adverse events	Oral	48	150

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24870446	RESULT

Source PubMed

Grants9

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U01MH070007	Relapse Prevention: Long-Acting Atypical Antipsychotics	MENDELOWITZ, ALAN	FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010	NIH RePORTER
U01MH070008	Relapse Prevention: Long Acting Atypical Antipsychotics	BUSTILLO, JUAN RICARDO	UNIVERSITY OF NEW MEXICO	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010	NIH RePORTER
U01MH070009	Relapse Prevention: Long-Acting Atypical Antipsychotics	GOFF, DONALD C.	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010	NIH RePORTER
U01MH070010	Relapse Prevention: Long-Acting Atypical Antipsychotics	MILLER, DEL D	UNIVERSITY OF IOWA	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010	NIH RePORTER
U01MH070011	Relapse Prevention: Long-Acting Atypical Antipsychotics	BUCKLEY, PETER F	AUGUSTA UNIVERSITY	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010	NIH RePORTER
U01MH070012	Relapse Prevention: Long-Acting Atypical Antipsychotics	KOPELOWICZ, ALEX J	UNIVERSITY OF CALIFORNIA LOS ANGELES	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010	NIH RePORTER
U01MH070016	Relapse Prevention: Long-Acting Atypical Antipsychotics	WILSON, DANIEL R	CREIGHTON UNIVERSITY	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010	NIH RePORTER
U01MH070017	Relapse Prevention: Long Acting Atypical Antipsychotics	MANSCHRECK, THEO C	BETH ISRAEL DEACONESS MEDICAL CENTER	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010	NIH RePORTER
U01MH070023	Relapse Prevention Study: Steering and Implementation	SCHOOLER, NINA R	FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH	NATIONAL INSTITUTE OF MENTAL HEALTH	2006 to 2010	NIH RePORTER

Trial comparisons2

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

Comparison	Source
Injectable vs Oral: Number of Patients Discontinuing From the Study	Trial comparisons
Injectable vs Oral: 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.

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