Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

Study Overview
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Brief Summary
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The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.

Detailed Description
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The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.

Official Title
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A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: paliperidone palmitate
* Drug: risperidone
* Drug: olanzapine
* Drug: aripiprazole
* Drug: haloperidole
* Drug: quetiapine
* Drug: perphenazine
* Drug: paliperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB) Must be an outpatient who, following an acute exacerbation of schizophrenia, has been discharged from an inpatient psychiatric hospital within 60 days of screening Have a current diagnosis of schizophrenia Have available a designated individual who is likely to have knowledge of the subject's health status and who agrees to let the study site personnel know of changes in the patient's circumstances Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control Exclusion Criteria: Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone Actively abusing intravenous drugs Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening have an unstable medical illness Women who are pregnant or breast-feeding, or planning to become pregnant Have received injectable antipsychotic treatment within 2 injection cycles prior to screening Received treatment with clozapine within 3 months of screening Attempted suicide within 6 months before screening or are at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at time of screening homeless at time of stuyd consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months | Drug: paliperidone palmitate<br>* 78, 117, 156, or 234 mg monthly injection for 12 months<br>|
| Active Comparator: 002<br>olanzapine flexible dosing as prescribed by the study doctor for 12 months | Drug: olanzapine<br>* flexible dosing as prescribed by the study doctor for 12 months<br>|
| Active Comparator: 003<br>paliperidone flexible dosing as prescribed by the study doctor for 12 months | Drug: paliperidone<br>* flexible dosing as prescribed by the study doctor for 12 months<br>|
| Active Comparator: 004<br>aripiprazole flexible dosing as prescribed by the study doctor for 12 months | Drug: aripiprazole<br>* flexible dosing as prescribed by the study doctor for 12 months<br>|
| Active Comparator: 005<br>haloperidole flexible dosing as prescribed by the study doctor for 12 months | Drug: haloperidole<br>* flexible dosing as prescribed by the study doctor for 12 months<br>|
| Active Comparator: 006<br>perphenazine flexible dosing as prescribed by the study doctor for 12 months | Drug: perphenazine<br>* flexible dosing as prescribed by the study doctor for 12 months<br>|
| Active Comparator: 007<br>quetiapine flexible dosing as prescribed by the study doctor for 12 months | Drug: quetiapine<br>* flexible dosing as prescribed by the study doctor for 12 months<br>|
| Active Comparator: 008<br>risperidone flexible dosing as prescribed by the study doctor for 12 months | Drug: risperidone<br>* flexible dosing as prescribed by the study doctor for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Global Impression-Severity score |  | Up to 12 months | 
| Change in Global Assessment of Functionality score |  | Up to 12 months | 
| Change in Medication Satisfaction Questionnaire score |  | Up to 12 months | 
| Proportion of subjects with at least one psychiatric hospitalization |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Risperidone, Risperdal, Paliperidone palmitate, Aripiprazole, Haloperidol, Olanzapine, Paliperidone, Perphenazine, Quetiapine