A Randomized, Double-blind, Placebo-controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Flexible-dose Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder.
Overview
- Phase
- Phase 3
- Intervention
- Paliperidone ER
- Conditions
- Schizoaffective Disorder
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Enrollment
- 307
- Primary Endpoint
- Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed Description
Schizophrenia and schizoaffective disorder are closely related in terms of symptoms, coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia, treatment with paliperidone extended-release (ER) improved psychotic symptoms, as well as mood symptoms evaluated by anxiety/depression and hostility/excitement Positive and Negative Symptoms of Schizophrenia (PANSS) factor scores. Therefore, paliperidone ER may also be effective in treating symptoms of schizoaffective disorder. Paliperidone's limited potential for drug-drug interaction is particularly important in this patient population, in which multiple drug therapy is relatively common. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo-controlled, parallel-group study is designed to examine the effectiveness and safety of paliperidone ER in adult patients with schizoaffective disorder who are experiencing an acute episode of this disorder. Patients in the study will be randomly assigned to 1 of 2 groups to receive 6 weeks of oral treatment with flexible dosages of paliperidone ER (3-12 mg/day) or with placebo. The primary efficacy outcome will be the change from baseline to Week 6, or the last post-randomization assessment during double-blind treatment (endpoint), in the PANSS total score. Safety will be assessed by monitoring adverse events, clinical laboratory testing, pregnancy testing, vital signs measurements, physical examination, administration of a 12-lead ECG, movement disorders side effect scales, and the InterSePT Scale for Suicidal Thinking. Patients may also choose to participate in a pharmacogenomic (DNA) analysis. The primary study hypothesis is that flexible-dose paliperidone ER is better than placebo on the change from baseline in the PANSS total score in acutely ill patients with schizoaffective disorder. Patients will receive study drug by mouth for a total of 43 days. Beginning on Day 1, patients will take either placebo or paliperidone ER 6 mg/day. After day 4, dosages may be adjusted, at defined intervals, to a dosage between 3 mg/day and 12 mg/day, inclusive.
Investigators
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
Arms & Interventions
001
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Intervention: Paliperidone ER
003
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Intervention: Paliperidone ER
002
Placebo for 6 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.
Time Frame: 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.
Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Time Frame: The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.
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 Outcomes
- Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.(Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment)
- Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline(Baseline)
- Participants With Response(Week 6 LOCF End Point)
- Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.(Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment)
- Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.(Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment)
- Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.(Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment)
- Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.(Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment)
- 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.(Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment)
- Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.(Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment)
- Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.(Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment)
- Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder(Week 6 or the last post-randomization assessment during double-blind treatment)
- Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.(Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment)