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

Janssen (J&J Innovative Medicine)

Status and phase: Withdrawn; Phase 4

Conditions: Schizophrenia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193166

CR017110

R092670SCH4003

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 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.

Full description

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.

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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 8 patient groups

001

Experimental group

Description:

paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months

Treatment:

Drug: paliperidone palmitate

002

Active Comparator group

Description:

olanzapine flexible dosing as prescribed by the study doctor for 12 months

Treatment:

Drug: olanzapine

003

Active Comparator group

Description:

paliperidone flexible dosing as prescribed by the study doctor for 12 months

Treatment:

Drug: paliperidone

004

Active Comparator group

Description:

aripiprazole flexible dosing as prescribed by the study doctor for 12 months

Treatment:

Drug: aripiprazole

005

Active Comparator group

Description:

haloperidole flexible dosing as prescribed by the study doctor for 12 months

Treatment:

Drug: haloperidole

006

Active Comparator group

Description:

perphenazine flexible dosing as prescribed by the study doctor for 12 months

Treatment:

Drug: perphenazine

007

Active Comparator group

Description:

quetiapine flexible dosing as prescribed by the study doctor for 12 months

Treatment:

Drug: quetiapine

008

Active Comparator group

Description:

risperidone flexible dosing as prescribed by the study doctor for 12 months

Treatment:

Drug: risperidone