The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.
The primary objective of this study is to compare the efficacy of paliperidone palmitate with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated. Protocol-defined treatment failure is defined as arrest, psychiatric hospitalization, increase in psychiatric services to prevent imminent hospitalization, discontinuation of antipsychotic treatment due to inadequate efficacy, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to safety or tolerability or completed suicide. Protocol was amended on March 15, 2011 to reflect changes in the inclusion/exclusion criteria as well as the study objectives. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for fifteen months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
450
flexible dosing as prescribed by the study doctor for 15 months
flexible dosing as prescribed by the study doctor for 15 months
flexible dosing as prescribed by the study doctor for 15 months
Time to First Treatment Failure
Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.
Time frame: From date of randomization up to Month 15
Percentage of Participants in Each Event Category of First Treatment Failure
First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.
Time frame: From date of randomization up to Month 15
Time to First Psychiatric Hospitalization or Arrest/Incarceration
A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia.
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flexible dosing as prescribed by the study doctor for 15 months
flexible dosing as prescribed by the study doctor for 15 months
flexible dosing as prescribed by the study doctor for 15 months
78, 117, 156, or 234 mg monthly injection for 15 months
flexible dosing as prescribed by the study doctor for 15 months
Unnamed facility
Bullhead City, Arizona, United States
Unnamed facility
Tuscon, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Escondido, California, United States
Unnamed facility
Glendale, California, United States
Unnamed facility
Imperial, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
National City, California, United States
Unnamed facility
Oakland, California, United States
...and 46 more locations
Time frame: From date of randomization up to Month 15
Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score \<=30 represents poor function that requires intensive supervision.
Time frame: Baseline up to Month 15
Time to First Psychiatric Hospitalization
A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the "Assessment of Treatment Failure - Psychiatric Hospitalization."
Time frame: From date of randomization up to Month 15
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.
Time frame: Baseline up to Month 15