Phase 3 N=304 Randomized Quadruple-blind Treatment

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

Schizoaffective Disorder · Psychotic Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00412373 ↗

Enrolled (actual)

304

Serious AEs

6.2%

Results posted

Dec 2009

Primary outcome: Primary: Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline. — 91.7; 92.3 points on a scale — p=0.774

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Paliperidone ER (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.	91.7; 92.3	0.774
PRIMARY Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-10.8; -20.0	<0.001 sig
SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-4.6; -7.3	<0.001 sig
SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-1.1; -3.0	<0.001 sig
SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-5.2; -9.7	<0.001 sig
SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-3.3; -6.0	<0.001 sig
SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-1.1; -3.1	<0.001 sig
SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-1.4; -3.3	<0.001 sig
SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-2.7; -4.3	0.001 sig
SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-2.3; -3.3	0.016 sig
SECONDARY Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline	4.6; 4.6	—
SECONDARY Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.	-0.7; -1.2	0.002 sig
SECONDARY Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder	3.4; 2.8	<0.001 sig
SECONDARY Participants With Response	26; 85	0.046 sig

Summary

The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.

Eligibility Criteria

Inclusion Criteria

Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder
A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of >= 60
A score of >= 16 on Young Mania Rating Scale (YMRS) or a score of >= 16 on the Hamilton Depression Rating Scale (HAM-D 21)

Exclusion Criteria

A primary active mental illness diagnosis other than schizoaffective disorder
Patients with first episode psychosis
Active substance dependence within previous 6 months
Treatment with clozapine within 6 months of randomization
A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication
Pregnancy, breast-feeding, or planning to become pregnant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00412373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.