Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-Release) Compared With Quetiapine in Patients With Schizophrenia
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: paliperidone ER tablets, quetiapine tablets, placebo - all overencapsulated (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 and 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 evaluate the efficacy (effectiveness of drug) and safety of
the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to
placebo in patients who are acutely ill with symptoms of schizophrenia.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Paliperidone ER Compared to Quetiapine in Subjects With an Acute Exacerbation of Schizophrenia
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Reduction in total PANSS ( Positive and Negative Syndrome Scale) from baseline to endpoint at Day 14
Secondary outcome: Time to response (based on reduction in PANSS plus Clinical Global Impression - Change) and readiness for discharge, utilization of health care resources and polypharmacy use in patients receiving paliperidone ER or quetiapine
Detailed description:
This is a randomized (patients are assigned different treatments based on chance), double
blind (neither the patient nor the physician knows whether drug or placebo is being taken, or
at what dosage), placebo controlled, parallel group study to compare the efficacy and safety
of paliperidone ER with quetiapine in the treatment of patients who have schizophrenia and
are acutely ill. The duration of the study is 42 days. During the first phase (Day 0 - Day
14) patients receive increasing doses of the treatment to which they are assigned (starting
with 3mg and increasing to 9 mg or 12 mg of paliperidone ER; starting with 50 mg and
increasing to 600 mg or 800 mg of quetiapine; or the same number of capsules of placebo).
During the second phase (Day 15 - Day 42), patients continue to take the dose of medication
they received on day 14, but may also receive other medications if the investigator
determines they are needed to treat ongoing symptoms. The hypothesis of the study is that
paliperidone ER is better than quetiapine in the short term for treating acutely ill patients
with schizophrenia. Primary outcome is change on the total score of the PANSS (Positive and
Negative Syndrome scale for Schizophrenia) in the first phase of the study (Day 0 - Day 14).
Secondary outcomes include time to response, time to readiness for discharge, and additional
medication use in the second phase of the study (Day 15- Day 42) for patients receiving
paliperidone ER compared to quetiapine. Safety of paliperidone ER compared with quetiapine
throughout the study (Day 0 - Day 42) will be based on reported adverse events, results of
laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure,
pulse, and weight), electrocardiogram, and movement disorder scales (Abnormal Involuntary
Movement Scale, Barnes Akathisia Scale, and Simpson-Angus Rating Scale). Patients may
participate in a pharmacogenomic (DNA) analysis, if they choose to do so.
Patients receive study drug by mouth for a total of 42 days. Study medications will be
increased to maximum tolerated doses of Paliperidone ER 9mg or 12mg/day and Quetiapine 600mg
or 800mg at day 8. From day 15 through day 42 (end of study) all patients will be eligible
for additional psychotropic medications at investigators' discretion.
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 schizophrenia
(paranoid, disorganized or undifferentiated type)
Score of >=4 on at least two of a subset of selected PANSS items and a total score on these
five items of >=17
Score of >=5 on the CGI-S (clinical global impression - severity)
Body weight of at least 60kg and willing to be hospitalized for 9 days initially
Exclusion Criteria:
A primary active mental illness diagnosis other than schizophrenia
Subjects whose psychotic symptoms can be explained by substance intake or medical
illness
Pregnancy, breast-feeding, or planning to become pregnant
A history of treatment resistance (defined by failure to respond to 2 adequate trials of
different antipsychotic medications or clozapine given at adequate dose for sufficient
time)
Unstable or signficant medical illness that would increase risk of taking study medication
or would confuse the interpretation of the study
Locations and Contacts
Additional Information
For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm
Starting date: May 2006
Ending date: July 2007
Last updated: October 11, 2007
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