15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01157351
First received: May 3, 2010
Last updated: February 3, 2014
Last verified: February 2014
  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:


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 ]

Enrollment: 453
Study Start Date: May 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 56 Study Locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

No publications provided

Responsible Party: 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: February 3, 2014
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
Risperidone
Aripiprazole
Quetiapine
Olanzapine
9-hydroxy-risperidone
Perphenazine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014