Trial · NCT00397033

Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.

NCT00397033, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2009-07-28

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ConductScience Library. Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder. Trials, record NCT00397033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00397033

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Trial

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

Title: Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
NCT number: NCT00397033
Status: Completed
Phases: Phase 3
Enrollment: 316 participants, actual
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions: Schizoaffective Disorder, Psychotic Disorder
Interventions: Paliperidone ER, Paliperidone ER, Placebo
First posted: 2006-11-08
Last updated: 2013-07-29
Results first posted: 2009-07-28

Source ClinicalTrials.gov

Registered outcomes18

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

List	Outcome	Time frame	Description
Primary	Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score	Baseline	The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Primary	The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.	Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point	The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Secondary	Number of Participants With Response	Baseline to Week 6 LOCF End Point	Response is defined as a 30% or more reduction from baseline in PANSS total score and a CGI-C score of \<= 2. (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder). The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject.
Secondary	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score	Baseline to Week 6 LOCF End Point	Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.
Secondary	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score	Baseline to Week 6 LOCF End Point	Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.
Secondary	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score	Baseline to Week 6 LOCF End Point	General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.
Secondary	Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score	Baseline to Week 6 LOCF End Point	Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.
Secondary	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score	Baseline to Week 6 LOCF End Point	Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.
Secondary	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score	Baseline to Week 6 LOCF End Point	Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.
Secondary	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score	Baseline to Week 6 LOCF End Point	Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score	Baseline	The Intent-to-Treat population included all randomized participants who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.	points on a scale	MEAN
SECONDARY	Number of Participants With Response	Baseline to Week 6 LOCF End Point	Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.	count of participants	NUMBER
SECONDARY	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score	Baseline to Week 6 LOCF End Point	Intent-to-Treat population.	points on subscale	MEAN
SECONDARY	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score	Baseline to Week 6 LOCF End Point	Intent-to-Treat population	points on a subscale	MEAN
SECONDARY	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score	Baseline to Week 6 LOCF End Point	Intent-to-Treat population	points on a subscale	MEAN
SECONDARY	Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score	Baseline to Week 6 LOCF End Point	Intent-to-Treat population.	points on a subscale	MEAN
OTHER_PRE_SPECIFIED	Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16	Baseline	Intent-to-Treat population with a baseline HAM-D-21 total score of \>= 16.	points on a scale	MEAN
OTHER_PRE_SPECIFIED	Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16	Baseline to Week 6 LOCF End Point	Intent-to-Treat population with a baseline HAM-D-21 total score of \>= 16.	points on scale	MEAN
SECONDARY	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score	Baseline to Week 6 LOCF End Point	Intent-to-Treat population	points on a subscale	MEAN
SECONDARY	Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score	Baseline to Week 6 LOCF End Point	Intent-to-Treat population	points on a subscale	MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group54

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

Outcome	Group	Value	Spread	Units
Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score	Placebo	91.6	Standard Deviation 12.5	points on a scale
Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score	Paliperidone Extended Release (ER) Low Dose	95.9	Standard Deviation 13.0	points on a scale
Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score	Paliperidone Extended Release (ER) High Dose	92.7	Standard Deviation 12.6	points on a scale
Number of Participants With Response	Placebo	40		count of participants
Number of Participants With Response	Paliperidone Extended Release (ER) Low Dose	57		count of participants
Number of Participants With Response	Paliperidone Extended Release (ER) High Dose	62		count of participants
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score	Placebo	-7.9	Standard Deviation 6.6	points on subscale
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score	Paliperidone Extended Release (ER) Low Dose	-9.1	Standard Deviation 7.1	points on subscale
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score	Paliperidone Extended Release (ER) High Dose	-11.3	Standard Deviation 6.3	points on subscale
Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score	Placebo	-3.1	Standard Deviation 5.1	points on a subscale

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	107
Overall Study	STARTED	Paliperidone Extended Release (ER) Low Dose	109
Overall Study	STARTED	Paliperidone Extended Release (ER) High Dose	100
Overall Study	Safety Population: >= 1 Dose of Drug	Placebo	107
Overall Study	Safety Population: >= 1 Dose of Drug	Paliperidone Extended Release (ER) Low Dose	108
Overall Study	Safety Population: >= 1 Dose of Drug	Paliperidone Extended Release (ER) High Dose	98
Overall Study	ITT Population	Placebo	107
Overall Study	ITT Population	Paliperidone Extended Release (ER) Low Dose	105
Overall Study	ITT Population	Paliperidone Extended Release (ER) High Dose	98
Overall Study	COMPLETED	Placebo	63

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events81

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	Constipation	Gastrointestinal disorders	Placebo	2	107	2
other	Constipation	Gastrointestinal disorders	Paliperidone Extended Release (ER) Low Dose	4	108	4
other	Constipation	Gastrointestinal disorders	Paliperidone Extended Release (ER) High Dose	5	98	8
other	Dry Mouth	Gastrointestinal disorders	Placebo	4	107	4
other	Dry Mouth	Gastrointestinal disorders	Paliperidone Extended Release (ER) Low Dose	7	108	8
other	Dry Mouth	Gastrointestinal disorders	Paliperidone Extended Release (ER) High Dose	2	98	2
other	Nausea	Gastrointestinal disorders	Placebo	8	107	9
other	Nausea	Gastrointestinal disorders	Paliperidone Extended Release (ER) Low Dose	9	108	11
other	Nausea	Gastrointestinal disorders	Paliperidone Extended Release (ER) High Dose	8	98	14
other	Nasopharyngitis	Infections and infestations	Placebo	2	107	2

1 to 10 of 81Source ClinicalTrials.gov

See all 81 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Paliperidone Extended Release (ER) Low Dose
Total, all-cause mortality	Paliperidone Extended Release (ER) High Dose
Total, other adverse events	Placebo	61	107
Total, other adverse events	Paliperidone Extended Release (ER) Low Dose	78	108
Total, other adverse events	Paliperidone Extended Release (ER) High Dose	68	98
Total, serious adverse events	Placebo	6	107
Total, serious adverse events	Paliperidone Extended Release (ER) Low Dose	10	108
Total, serious adverse events	Paliperidone Extended Release (ER) High Dose	2	98

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20492853	DERIVED	PubMed
26934062	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.

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