Clinical trial NCT00412373: Evaluation of Effectiveness and Safety of Flexible-dose 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 Flexible-dose 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: 2006-12-18
Enrollment: 307
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 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.

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: Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.
timeFrame: Baseline
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: 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.
Secondary outcomes:
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: 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.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline
timeFrame: Baseline
measure: Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder
timeFrame: Week 6 or the last post-randomization assessment during double-blind treatment
measure: Participants With Response
timeFrame: Week 6 LOCF End Point
Other outcomes:
measure: Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
timeFrame: Baseline
measure: Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
measure: Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
timeFrame: Baseline
measure: Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
timeFrame: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Locations:
city: Cerritos
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Ahmedabad
country: India
city: Ahmedibad
country: India
city: Aurangabad
country: India
city: Chennai
country: India
city: Delhi
country: India
city: Kanpur Uttarpradeh
country: India
city: Pune
country: India
city: Vadadora
country: India
city: Chonju
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gyeonggi-Do
country: Korea, Republic of
city: Inchun
country: Korea, Republic of
city: Kwangiu
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Ipoh
country: Malaysia
city: Kota Kinabalu
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuching
country: Malaysia
city: Davao City
country: Philippines
city: Mandaluyong
country: Philippines
city: Manila
country: Philippines
city: Pasig National Capitol Region
country: Philippines
city: Arad
country: Romania
city: Bucharest
country: Romania
city: Campina
country: Romania
city: Com Gura Ocnitei
country: Romania
city: Iasi
country: Romania
city: Pitesti
country: Romania
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.