15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: quetiapine; Drug: haloperidole; Drug: paliperidone palmitate; Drug: paliperidone; Drug: aripiprazole; Drug: olanzapine; Drug: risperidone; Drug: perphenazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01157351

R092670SCH3006 (Other Identifier)

CR015625

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 450 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 8 patient groups

001

Experimental group

Description:

paliperidone palmitate 78 117 156 or 234 mg monthly injection for 15 months

Treatment:

Drug: paliperidone palmitate

002

Active Comparator group

Description:

aripiprazole flexible dosing as prescribed by the study doctor for 15 months

Treatment:

Drug: aripiprazole

003

Active Comparator group

Description:

haloperidole flexible dosing as prescribed by the study doctor for 15 months

Treatment:

Drug: haloperidole

004

Active Comparator group

Description:

olanzapine flexible dosing as prescribed by the study doctor for 15 months

Treatment:

Drug: olanzapine

005

Active Comparator group

Description:

paliperidone flexible dosing as prescribed by the study doctor for 15 months

Treatment:

Drug: paliperidone

006

Active Comparator group

Description:

perphenazine flexible dosing as prescribed by the study doctor for 15 months

Treatment:

Drug: perphenazine

007

Active Comparator group

Description:

quetiapine flexible dosing as prescribed by the study doctor for 15 months

Treatment:

Drug: quetiapine

008

Active Comparator group

Description:

risperidone flexible dosing as prescribed by the study doctor for 15 months

Treatment:

Drug: risperidone