15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: paliperidone; risperidone; haloperidole; perphenazine; aripiprazole; quetiapine; paliperidone palmitate; olanzapine
Intervention description: 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; 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
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate; Perphenazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 450.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Risperidone; Risperdal; Paliperidone palmitate; Aripiprazole; Haloperidol; Olanzapine; Paliperidone; Perphenazine; Quetiapine

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be able to understand and sign the informed consent form approved by the
             Institutional Review Board (IRB)

          -  Must successfully answer all the questions on the Informed Consent quiz indicating
             that they understand the purpose of and procedures required for the study and are
             willing to participate in the study

          -  Have a current diagnosis of schizophrenia

          -  Taking no more than 1 oral antipsychotic on the day before randomization

          -  Have been placed into custody at least twice with one of them leading to incarceration
             within the 24 months previous to study start, with the last release occurring within
             the 90 days before the first day of screening

          -  in the opinion of the investigator, may benefit from a change in their prior
             antipsychotic treatment

          -  Have available a designated individual (eg, family member, case manager, significant
             other, probation/parole officer) who has knowledge of the patient and is generally
             aware of the patient's daily activities, and who agrees to let the study site
             personnel know of changes in the patients circumstances when the patient is not able
             to provide this information, ie, arrests, protocol-defined hospitalizations, emergency
             room visits, becoming homeless, etc.

          -  Have either an address or phone number where they can be reached, or be accessible to
             the designated individual

          -  Must agree to receive regular injections for 15 months if randomly assigned to the
             paliperidone palmitate treatment group, or continue with oral study medication
             treatment for 15 months if randomly assigned to the oral antipsychotic treatment group

          -  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 within the past 3 months or have an opiate
             dependence disorder

          -  Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or
             opiates at screening

          -  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

          -  Are at a high risk of violence in the next 15 months, in the opinion of the
             investigator

          -  who have a history of sex offenses including felony sex offenses, child molestation