Phase 3
N=316
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Schizoaffective Disorder · Psychotic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00397033 ↗Enrolled (actual)
316
Serious AEs
5.8%
Results posted
Jul 2009
Primary outcome: Primary: Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score — 91.6; 95.9; 92.7 points on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paliperidone ER (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score |
91.6; 95.9; 92.7 | — |
| 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. |
-21.7; -27.4; -30.6 | 0.003 sig |
| SECONDARY Number of Participants With Response |
40; 57; 62 | 0.001 sig |
| SECONDARY Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score |
-7.9; -9.1; -11.3 | <0.001 sig |
| SECONDARY Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score |
-3.1; -4.4; -4.2 | 0.108 |
| SECONDARY Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score |
-10.7; -13.9; -15.1 | 0.008 sig |
| SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score |
-6.7; -8.0; -9.6 | 0.001 sig |
| SECONDARY Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score |
-3.0; -4.5; -4.0 | 0.232 |
| SECONDARY Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score |
-3.7; -5.0; -5.7 | 0.004 sig |
| SECONDARY Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score |
-4.8; -5.4; -7.0 | <0.001 sig |
| SECONDARY Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score |
-3.4; -4.5; -4.3 | 0.071 |
| SECONDARY Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline |
4.6; 4.6; 4.6 | — |
| SECONDARY Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder |
-1.1; -1.4; -1.8 | <0.001 sig |
| SECONDARY Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder |
2.9; 2.6; 2.2 | <0.001 sig |
Summary
The purpose of this study is to measure the effectiveness and assess the safety of two dosages 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
Data sourced from ClinicalTrials.gov (NCT00397033). 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.