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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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001

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

Group Type EXPERIMENTAL

paliperidone palmitate

Intervention Type DRUG

78, 117, 156, or 234 mg monthly injection for 12 months

002

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

Group Type ACTIVE_COMPARATOR

olanzapine

Intervention Type DRUG

flexible dosing as prescribed by the study doctor for 12 months

003

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

Group Type ACTIVE_COMPARATOR

paliperidone

Intervention Type DRUG

flexible dosing as prescribed by the study doctor for 12 months

004

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

Group Type ACTIVE_COMPARATOR

aripiprazole

Intervention Type DRUG

flexible dosing as prescribed by the study doctor for 12 months

005

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

Group Type ACTIVE_COMPARATOR

haloperidole

Intervention Type DRUG

flexible dosing as prescribed by the study doctor for 12 months

006

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

Group Type ACTIVE_COMPARATOR

perphenazine

Intervention Type DRUG

flexible dosing as prescribed by the study doctor for 12 months

007

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

Group Type ACTIVE_COMPARATOR

quetiapine

Intervention Type DRUG

flexible dosing as prescribed by the study doctor for 12 months

008

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

Group Type ACTIVE_COMPARATOR

risperidone

Intervention Type DRUG

flexible dosing as prescribed by the study doctor for 12 months

Interventions

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paliperidone palmitate

78, 117, 156, or 234 mg monthly injection for 12 months

Intervention Type DRUG

risperidone

flexible dosing as prescribed by the study doctor for 12 months

Intervention Type DRUG

olanzapine

flexible dosing as prescribed by the study doctor for 12 months

Intervention Type DRUG

aripiprazole

flexible dosing as prescribed by the study doctor for 12 months

Intervention Type DRUG

haloperidole

flexible dosing as prescribed by the study doctor for 12 months

Intervention Type DRUG

quetiapine

flexible dosing as prescribed by the study doctor for 12 months

Intervention Type DRUG

perphenazine

flexible dosing as prescribed by the study doctor for 12 months

Intervention Type DRUG

paliperidone

flexible dosing as prescribed by the study doctor for 12 months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No