Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizoaffective Disorder; Psychotic Disorder
Intervention: Placebo (Drug); Paliperidone ER (Drug); Paliperidone ER (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Secondary outcome: Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (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. Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. 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. Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder Participants With Response
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Ahmedabad, India
Ahmedibad, India
Aurangabad, India
Chennai, India
Delhi, India
Kanpur Uttarpradeh, India
Pune, India
Vadadora, India
Chonju, Korea, Republic of
Daegu, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Inchun, Korea, Republic of
Kwangiu, Korea, Republic of
Pusan, Korea, Republic of
Seoul, Korea, Republic of
Ipoh, Malaysia
Kota Kinabalu, Malaysia
Kuala Lumpur, Malaysia
Kuching, Malaysia
Davao City, Philippines
Mandaluyong, Philippines
Manila, Philippines
Pasig National Capitol Region, Philippines
Arad, Romania
Bucharest, Romania
Campina, Romania
Com Gura Ocnitei, Romania
Iasi, Romania
Pitesti, Romania
Cerritos, California, United States
Costa Mesa, California, United States
Garden Grove, California, United States
Huntington Beach, California, United States
Pico Rivera, California, United States
San Diego, California, United States
Aventura, Florida, United States
Hollywood, Florida, United States
Kissimmee, Florida, United States
Leesburg, Florida, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Irving, Texas, United States
Additional Information
Evaluation of Effectiveness and Safety of Flexible-Dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Starting date: December 2006
Last updated: April 24, 2014
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