Trial · NCT00589914

Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia

NCT00589914, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2011-10-04

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia. Trials, record NCT00589914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00589914

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Trial

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

Title: Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
NCT number: NCT00589914
Status: Completed
Phases: Phase 3
Enrollment: 1,221 participants, actual
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions: Schizophrenia
Interventions: RISPERDAL CONSTA, Paliperidone palmitate
First posted: 2008-01-10
Last updated: 2014-06-24
Results first posted: 2011-10-04
Limitations and caveats: Of 1221 patients randomized, one patient was enrolled twice and assigned 2 patient numbers. Only the first patient number is included in the results reported for 1220 randomized patients.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia	Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)	The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).
Secondary	The Change From Baseline for the CGI-S Score	Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]	The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient's condition at a given time. A qualified rater administered the CGI-S.
Secondary	The Change From Baseline in the PSP Score	Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)	The PSP scale is used to assess the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numeric score. A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a patient with a score of 30 or less has functioning so poor he or she requires intensive supervision.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia	Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)	The per-protocol analysis set of patients included those randomized to treatment after IEC/ IRB approval of protocol Amendment INT-4 with both a baseline measurement and at least 1 postrandomization measurement on the primary efficacy variable, a minimum exposure of 36 days to the double-blind treatment regimen, and no major protocol violations.	Scores on a scale	MEAN
SECONDARY	The Change From Baseline for the CGI-S Score	Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]	The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.	Scores on a scale	MEAN
SECONDARY	The Change From Baseline in the PSP Score	Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)	The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.	Scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia	R092670	-18.6	Standard Deviation 15.45	Scores on a scale
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia	RISPERDAL CONSTA	-17.9	Standard Deviation 14.24	Scores on a scale
The Change From Baseline for the CGI-S Score	R092670	-0.9	Standard Deviation 0.97	Scores on a scale
The Change From Baseline for the CGI-S Score	RISPERDAL CONSTA	-0.9	Standard Deviation 0.93	Scores on a scale
The Change From Baseline in the PSP Score	R092670	8.5	Standard Deviation 11.82	Scores on a scale
The Change From Baseline in the PSP Score	RISPERDAL CONSTA	8.8	Standard Deviation 11.65	Scores on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	R092670	606
Overall Study	STARTED	RISPERDAL CONSTA	608
Overall Study	COMPLETED	R092670	456
Overall Study	COMPLETED	RISPERDAL CONSTA	471
Overall Study	NOT COMPLETED	R092670	150
Overall Study	NOT COMPLETED	RISPERDAL CONSTA	137

Source ClinicalTrials.gov

Adverse events58

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	Injection site pain	General disorders	R092670	31	606
other	Injection site pain	General disorders	RISPERDAL CONSTA	5	608
other	Headache	Nervous system disorders	R092670	43	606
other	Headache	Nervous system disorders	RISPERDAL CONSTA	44	608
other	Somnolence	Nervous system disorders	R092670	34	606
other	Somnolence	Nervous system disorders	RISPERDAL CONSTA	24	608
other	Insomnia	Psychiatric disorders	R092670	57	606
other	Insomnia	Psychiatric disorders	RISPERDAL CONSTA	41	608
serious	Constipation	Gastrointestinal disorders	R092670	0	606
serious	Constipation	Gastrointestinal disorders	RISPERDAL CONSTA	1	608

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	R092670
Total, all-cause mortality	RISPERDAL CONSTA
Total, other adverse events	R092670	147	606
Total, other adverse events	RISPERDAL CONSTA	108	608
Total, serious adverse events	R092670	41	606
Total, serious adverse events	RISPERDAL CONSTA	29	608

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21092748	DERIVED	PubMed
23446197	DERIVED	PubMed
24113628	DERIVED	PubMed
24754314	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 comparisons1

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

Comparison
R092670 vs RISPERDAL CONSTA: 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.

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The record and each of its lists are JSON, twenty rows a page. No key.

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