Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
Schizophrenia
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Risperdal, Paliperidone palmitate, Aripiprazole, Haloperidol, Olanzapine, Paliperidone, Perphenazine, Quetiapine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
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paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months
olanzapine flexible dosing as prescribed by the study doctor for 12 months
paliperidone flexible dosing as prescribed by the study doctor for 12 months
aripiprazole flexible dosing as prescribed by the study doctor for 12 months
haloperidole flexible dosing as prescribed by the study doctor for 12 months
perphenazine flexible dosing as prescribed by the study doctor for 12 months
quetiapine flexible dosing as prescribed by the study doctor for 12 months
risperidone flexible dosing as prescribed by the study doctor for 12 months