Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
Phase 4
Withdrawn
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT01193166
- Lead Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 005 haloperidole haloperidole flexible dosing as prescribed by the study doctor for 12 months 006 perphenazine perphenazine flexible dosing as prescribed by the study doctor for 12 months 001 paliperidone palmitate paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months 002 olanzapine olanzapine flexible dosing as prescribed by the study doctor for 12 months 003 paliperidone paliperidone flexible dosing as prescribed by the study doctor for 12 months 004 aripiprazole aripiprazole flexible dosing as prescribed by the study doctor for 12 months 008 risperidone risperidone flexible dosing as prescribed by the study doctor for 12 months 007 quetiapine quetiapine flexible dosing as prescribed by the study doctor for 12 months
- Primary Outcome Measures
Name Time Method Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services Up to 12 months
- Secondary Outcome Measures
Name Time Method Change in Clinical Global Impression-Severity score Up to 12 months Change in Global Assessment of Functionality score Up to 12 months Change in Medication Satisfaction Questionnaire score Up to 12 months Proportion of subjects with at least one psychiatric hospitalization Up to 12 months