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

• Status: Withdrawn
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Antipsychotic Agents; Aripiprazole; Olanzapine; Paliperidone Palmitate; Perphenazine; Quetiapine Fumarate; Risperidone

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