Back to results15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
paliperidone
risperidone
haloperidole
perphenazine
aripiprazole
quetiapine
paliperidone palmitate
olanzapine
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Risperdal, Paliperidone palmitate, Aripiprazole, Haloperidol, Olanzapine, Paliperidone, Perphenazine, Quetiapine
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
001
002
003
004
005
006
007
008
Arm Description
paliperidone palmitate 78 117 156 or 234 mg monthly injection for 15 months
aripiprazole flexible dosing as prescribed by the study doctor for 15 months
haloperidole flexible dosing as prescribed by the study doctor for 15 months
olanzapine flexible dosing as prescribed by the study doctor for 15 months
paliperidone flexible dosing as prescribed by the study doctor for 15 months
perphenazine flexible dosing as prescribed by the study doctor for 15 months
quetiapine flexible dosing as prescribed by the study doctor for 15 months
risperidone flexible dosing as prescribed by the study doctor for 15 months
Outcomes
Primary Outcome Measures
Time to First Treatment Failure
Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.
Percentage of Participants in Each Event Category of First Treatment Failure
First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.
Secondary Outcome Measures
Time to First Psychiatric Hospitalization or Arrest/Incarceration
A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia.
Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision.
Time to First Psychiatric Hospitalization
A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the "Assessment of Treatment Failure - Psychiatric Hospitalization."
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.
Full Information
NCT ID
NCT01157351
First Posted
May 3, 2010
Last Updated
April 7, 2015
Sponsor
Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01157351
Brief Title
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Scientific Affairs, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 15 months, in patients diagnosed with schizophrenia who have been incarcerated.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Risperidone, Risperdal, Paliperidone palmitate, Aripiprazole, Haloperidol, Olanzapine, Paliperidone, Perphenazine, Quetiapine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
paliperidone palmitate 78 117 156 or 234 mg monthly injection for 15 months
Arm Title
002
Arm Type
Active Comparator
Arm Description
aripiprazole flexible dosing as prescribed by the study doctor for 15 months
Arm Title
003
Arm Type
Active Comparator
Arm Description
haloperidole flexible dosing as prescribed by the study doctor for 15 months
Arm Title
004
Arm Type
Active Comparator
Arm Description
olanzapine flexible dosing as prescribed by the study doctor for 15 months
Arm Title
005
Arm Type
Active Comparator
Arm Description
paliperidone flexible dosing as prescribed by the study doctor for 15 months
Arm Title
006
Arm Type
Active Comparator
Arm Description
perphenazine flexible dosing as prescribed by the study doctor for 15 months
Arm Title
007
Arm Type
Active Comparator
Arm Description
quetiapine flexible dosing as prescribed by the study doctor for 15 months
Arm Title
008
Arm Type
Active Comparator
Arm Description
risperidone flexible dosing as prescribed by the study doctor for 15 months
Intervention Type
Drug
Intervention Name(s)
paliperidone
Intervention Description
flexible dosing as prescribed by the study doctor for 15 months
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Description
flexible dosing as prescribed by the study doctor for 15 months
Intervention Type
Drug
Intervention Name(s)
haloperidole
Intervention Description
flexible dosing as prescribed by the study doctor for 15 months
Intervention Type
Drug
Intervention Name(s)
perphenazine
Intervention Description
flexible dosing as prescribed by the study doctor for 15 months
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Intervention Description
flexible dosing as prescribed by the study doctor for 15 months
Intervention Type
Drug
Intervention Name(s)
quetiapine
Intervention Description
flexible dosing as prescribed by the study doctor for 15 months
Intervention Type
Drug
Intervention Name(s)
paliperidone palmitate
Intervention Description
78, 117, 156, or 234 mg monthly injection for 15 months
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
flexible dosing as prescribed by the study doctor for 15 months
Primary Outcome Measure Information:
Title
Time to First Treatment Failure
Description
Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.
Time Frame
From date of randomization up to Month 15
Title
Percentage of Participants in Each Event Category of First Treatment Failure
Description
First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.
Time Frame
From date of randomization up to Month 15
Secondary Outcome Measure Information:
Title
Time to First Psychiatric Hospitalization or Arrest/Incarceration
Description
A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia.
Time Frame
From date of randomization up to Month 15
Title
Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
Description
The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision.
Time Frame
Baseline up to Month 15
Title
Time to First Psychiatric Hospitalization
Description
A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the "Assessment of Treatment Failure - Psychiatric Hospitalization."
Time Frame
From date of randomization up to Month 15
Title
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
Description
The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.
Time Frame
Baseline up to Month 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Scientific Affairs, LLC Clinical Trial
Organizational Affiliation
Janssen Scientific Affairs, LLC
Official's Role
Study Director
Facility Information:
City
Bullhead City
State/Province
Arizona
Country
United States
City
Tuscon
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Escondido
State/Province
California
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Imperial
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
National City
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
City
Oceanside
State/Province
California
Country
United States
City
Pico Rivera
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
San Bernadino
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Fran Cisco
State/Province
California
Country
United States
City
New Britain
State/Province
Connecticut
Country
United States
City
New London
State/Province
Connecticut
Country
United States
City
Leesburg
State/Province
Florida
Country
United States
City
Miami Gardens
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Pensacola
State/Province
Florida
Country
United States
City
Tamarac
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Honolulu
State/Province
Hawaii
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Hoffman Estates
State/Province
Illinois
Country
United States
City
Naperville
State/Province
Illinois
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Witchita
State/Province
Kansas
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Flowood
State/Province
Mississippi
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Paramus
State/Province
New Jersey
Country
United States
City
Willingboro
State/Province
New Jersey
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Middleburg Heights
State/Province
Ohio
Country
United States
City
Willoughby
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Desoto
State/Province
Texas
Country
United States
City
Irving
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Wharton
State/Province
Texas
Country
United States
City
Bothell
State/Province
Washington
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Rio Piedras
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
33988924
Citation
Bell Lynum KS, Henderson DC, Wright HJ, Gogate JP, Kim E. Treatment Effect With Paliperidone Palmitate Compared With Oral Antipsychotics in Black/African American Patients With Schizophrenia and a History of Criminal Justice System Involvement: A Post Hoc Analysis of the PRIDE Study. J Clin Psychiatry. 2021 Feb 23;82(2):20m13356. doi: 10.4088/JCP.20m13356.
Results Reference
derived
PubMed Identifier
26742509
Citation
Alphs L, Mao L, Lynn Starr H, Benson C. A pragmatic analysis comparing once-monthly paliperidone palmitate versus daily oral antipsychotic treatment in patients with schizophrenia. Schizophr Res. 2016 Feb;170(2-3):259-64. doi: 10.1016/j.schres.2015.12.012. Epub 2015 Dec 29.
Results Reference
derived
PubMed Identifier
26403322
Citation
Alphs L, Bossie C, Mao L, Lee E, Starr HL. Treatment effect with paliperidone palmitate compared with oral antipsychotics in patients with recent-onset versus more chronic schizophrenia and a history of criminal justice system involvement. Early Interv Psychiatry. 2018 Feb;12(1):55-65. doi: 10.1111/eip.12271. Epub 2015 Sep 25.
Results Reference
derived
PubMed Identifier
25938474
Citation
Alphs L, Benson C, Cheshire-Kinney K, Lindenmayer JP, Mao L, Rodriguez SC, Starr HL. Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board-blinded 15-month study. J Clin Psychiatry. 2015 May;76(5):554-61. doi: 10.4088/JCP.14m09584.
Results Reference
derived
PubMed Identifier
25375367
Citation
Alphs L, Mao L, Rodriguez SC, Hulihan J, Starr HL. Design and rationale of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study: a novel comparative trial of once-monthly paliperidone palmitate versus daily oral antipsychotic treatment for delaying time to treatment failure in persons with schizophrenia. J Clin Psychiatry. 2014 Dec;75(12):1388-93. doi: 10.4088/JCP.13m08965.
Results Reference
derived
Learn more about this trial
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
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