15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated - Full Text View

Sponsor:	Janssen Scientific Affairs, LLC
Information provided by:	Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT01157351

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 15 months, in patients diagnosed with schizophrenia who have been incarcerated

Condition	Intervention	Phase
Schizophrenia	Drug: paliperidone Drug: risperidone Drug: haloperidole Drug: perphenazine Drug: aripiprazole Drug: quetiapine Drug: paliperidone palmitate Drug: olanzapine	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 Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

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

U.S. FDA Resources

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

Primary Outcome Measures:

Time to treatment failure defined as arrest, 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 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Clinical Global Impression-Severity (CGI-S) score [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]
Change in Personal and Social Performance Scale (PSP) [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]
Change in Medication Satisfaction Questionnaire score [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	442
Study Start Date:	April 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	July 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 15 months	Drug: paliperidone palmitate 78, 117, 156, or 234 mg monthly injection for 15 months
Active Comparator: 002 aripiprazole flexible dosing as prescribed by the study doctor for 15 months	Drug: aripiprazole flexible dosing as prescribed by the study doctor for 15 months
Active Comparator: 003 haloperidole flexible dosing as prescribed by the study doctor for 15 months	Drug: haloperidole flexible dosing as prescribed by the study doctor for 15 months
Active Comparator: 004 olanzapine flexible dosing as prescribed by the study doctor for 15 months	Drug: olanzapine flexible dosing as prescribed by the study doctor for 15 months
Active Comparator: 005 paliperidone flexible dosing as prescribed by the study doctor for 15 months	Drug: paliperidone flexible dosing as prescribed by the study doctor for 15 months
Active Comparator: 006 perphenazine flexible dosing as prescribed by the study doctor for 15 months	Drug: perphenazine flexible dosing as prescribed by the study doctor for 15 months
Active Comparator: 007 quetiapine flexible dosing as prescribed by the study doctor for 15 months	Drug: quetiapine flexible dosing as prescribed by the study doctor for 15 months
Active Comparator: 008 risperidone flexible dosing as prescribed by the study doctor for 15 months	Drug: risperidone flexible dosing as prescribed by the study doctor for 15 months

Detailed Description:

The primary objective of this study is to compare the efficacy of paliperidone palmitate with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated. Protocol-defined treatment failure is defined as arrest, psychiatric hospitalization, increase in psychiatric services to prevent imminent hospitalization, discontinuation of antipsychotic treatment due to inadequate efficacy, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to safety or tolerability or completed suicide. Protocol was amended on March 15, 2011 to reflect changes in the inclusion/exclusion criteria as well as the study objectives. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for fifteen 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 successfully answer all the questions on the Informed Consent quiz indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Have a current diagnosis of schizophrenia
Taking no more than 1 oral antipsychotic on the day before randomization
Have been placed into custody at least twice with one of them leading to incarceration within the 24 months previous to study start, with the last release occurring within the 90 days before the first day of screening
in the opinion of the investigator, may benefit from a change in their prior antipsychotic treatment
Have available a designated individual (eg, family member, case manager, significant other, probation/parole officer) who has knowledge of the patient and is generally aware of the patient's daily activities, and who agrees to let the study site personnel know of changes in the patients circumstances when the patient is not able to provide this information, ie, arrests, protocol-defined hospitalizations, emergency room visits, becoming homeless, etc.
Have either an address or phone number where they can be reached, or be accessible to the designated individual
Must agree to receive regular injections for 15 months if randomly assigned to the paliperidone palmitate treatment group, or continue with oral study medication treatment for 15 months if randomly assigned to the oral antipsychotic treatment group
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 within the past 3 months or have an opiate dependence disorder
Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
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
Are at a high risk of violence in the next 15 months, in the opinion of the investigator
who have a history of sex offenses including felony sex offenses, child molestation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157351

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

JNJ.CT@sylogent.com

Show 97 Study Locations

Sponsors and Collaborators

Janssen Scientific Affairs, LLC

Investigators

Study Director:

Janssen Scientific Affairs, LLC Clinical Trial

Janssen Scientific Affairs, LLC

More Information

Additional Information:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Vice President, CNS Medical Affairs, Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT01157351 History of Changes
Other Study ID Numbers:	CR015625, R092670SCH3006
Study First Received:	May 3, 2010
Last Updated:	May 18, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by 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
Risperidone
Quetiapine
Olanzapine
9-hydroxy-risperidone
Aripiprazole
Antipsychotic Agents
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 May 23, 2012