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

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: paliperidone palmitate Drug: risperidone Drug: olanzapine Drug: aripiprazole Drug: haloperidole Drug: quetiapine Drug: perphenazine Drug: paliperidone	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Perphenazine Risperidone Quetiapine Quetiapine fumarate Aripiprazole Olanzapine Paliperidone Paliperidone Palmitate Olanzapine pamoate

U.S. FDA Resources

Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Primary Outcome Measures:

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 [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Clinical Global Impression-Severity score [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Change in Global Assessment of Functionality score [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Change in Medication Satisfaction Questionnaire score [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Proportion of subjects with at least one psychiatric hospitalization [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months	Drug: paliperidone palmitate 78, 117, 156, or 234 mg monthly injection for 12 months
Active Comparator: 002 olanzapine flexible dosing as prescribed by the study doctor for 12 months	Drug: olanzapine flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 003 paliperidone flexible dosing as prescribed by the study doctor for 12 months	Drug: paliperidone flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 004 aripiprazole flexible dosing as prescribed by the study doctor for 12 months	Drug: aripiprazole flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 005 haloperidole flexible dosing as prescribed by the study doctor for 12 months	Drug: haloperidole flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 006 perphenazine flexible dosing as prescribed by the study doctor for 12 months	Drug: perphenazine flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 007 quetiapine flexible dosing as prescribed by the study doctor for 12 months	Drug: quetiapine flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 008 risperidone flexible dosing as prescribed by the study doctor for 12 months	Drug: risperidone flexible dosing as prescribed by the study doctor for 12 months

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193166

Sponsors and Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

Study Director:

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

Ortho-McNeil Janssen Scientific Affairs, LLC

More Information

No publications provided

Responsible Party:	Vice President, CNS Medical Affairs, Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT01193166 History of Changes
Other Study ID Numbers:	CR017110, R092670SCH4003
Study First Received:	August 30, 2010
Last Updated:	March 24, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Schizophrenia
Risperidone
Risperdal
Paliperidone palmitate
Aripiprazole

Haloperidol
Olanzapine
Paliperidone
Perphenazine
Quetiapine

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Perphenazine
Antipsychotic Agents
Risperidone
Quetiapine
Olanzapine
9-hydroxy-risperidone
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists
Serotonin Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013