Clinical trial NCT00397033: Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Two Dosages of Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizoaffective Disorder
Psychotic Disorder
Keywords: Schizoaffective Disorder
antipsychotic
paliperidone
placebo
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Janssen, LP
First posted: 2006-11-08
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 3 groups to receive 6 weeks of oral treatment with 1 of 2 dosages of paliperidone ER or 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 hypotheses are that at least one of the two dosages of paliperidone ER is better than placebo on the change from baseline in the PANSS total score in acutely ill patients with schizoaffective disorder at the end of 6 weeks of treatment. Patients will receive study drug by mouth for a total of 43 days. Beginning on Day 1, patients will take either placebo or 1 of 2 doses of paliperidone: 6 mg/day (low randomized dosage) or 12 mg/day (high randomized dosage). During the first 2 weeks, dosages may be adjusted.

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

Primary outcomes:
measure: Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score
timeFrame: Baseline
measure: 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.
timeFrame: Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point
Secondary outcomes:
measure: Number of Participants With Response
timeFrame: Baseline to Week 6 LOCF End Point
measure: Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score
timeFrame: Baseline to Week 6 LOCF End Point
measure: Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score
timeFrame: Baseline to Week 6 LOCF End Point
measure: Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score
timeFrame: Baseline to Week 6 LOCF End Point
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score
timeFrame: Baseline to Week 6 LOCF End Point
measure: Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score
timeFrame: Baseline to Week 6 LOCF End Point
measure: Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score
timeFrame: Baseline to Week 6 LOCF End Point
measure: Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score
timeFrame: Baseline to Week 6 LOCF End Point
measure: Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score
timeFrame: Baseline to Week 6 LOCF End Point
measure: Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline
timeFrame: Baseline
measure: Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder
timeFrame: Baseline to Week 6 LOCF End Point
measure: Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder
timeFrame: Week 6 LOCF End Point
Other outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
timeFrame: Baseline
measure: Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
timeFrame: Baseline to Week 6 LOCF End Point
measure: Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
timeFrame: Baseline
measure: Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
timeFrame: Baseline to Week 6 LOCF End Point
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Alphs L, Fu DJ, Turkoz I. Paliperidone for the treatment of schizoaffective disorder. Expert Opin Pharmacother. 2016;17(6):871-83. doi: 10.1517/14656566.2016.1161029. Epub 2016 Mar 24.
citation: Canuso CM, Lindenmayer JP, Kosik-Gonzalez C, Turkoz I, Carothers J, Bossie CA, Schooler NR. A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder. J Clin Psychiatry. 2010 May;71(5):587-98. doi: 10.4088/JCP.09m05564yel.