The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.
This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the efficacy of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years prior to screening. High risk of relapse is defined as having documented occurrence of 3 periods of breakthrough symptoms that required a change in patient care per the investigator's judgment (e.g., increase in dose, addition of a new drug, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, psychiatric hospitalization, etc.) within the previous 24 months, including 1 such period within the previous 6 months. Safety evaluations will include Adverse Event (AE) reporting, hematology and clinical chemistry laboratory tests, vital signs, electrocardiogram (ECG), and evaluations of suicidality and sexual functioning. Patients will receive either paliperidone palmitate 50, 75, 100, or 150 mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8 mg tabs once daily for two years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
163
50, 75, 100, or 150 mg eq. monthly injection for 2 years
2, 4, 6, or 8 mg tabs once daily for two years
Time to Relapse During Relapse Prevention Phase
Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.
Time frame: 24 months
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Little Rock, Arkansas, United States
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Garden Grove, California, United States
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San Diego, California, United States
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Washington D.C., District of Columbia, United States
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Kissimmee, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Hoffman Estates, Illinois, United States
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Kingsport, Indiana, United States
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Lake Charles, Louisiana, United States
...and 62 more locations