Clinical trial NCT01157351: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Risperidone
Risperdal
Paliperidone palmitate
Aripiprazole
Haloperidol
Olanzapine
Paliperidone
Perphenazine
Quetiapine
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2010-07-07
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Time to First Treatment Failure
timeFrame: From date of randomization up to Month 15
measure: Percentage of Participants in Each Event Category of First Treatment Failure
timeFrame: From date of randomization up to Month 15
Secondary outcomes:
measure: Time to First Psychiatric Hospitalization or Arrest/Incarceration
timeFrame: From date of randomization up to Month 15
measure: Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
timeFrame: Baseline up to Month 15
measure: Time to First Psychiatric Hospitalization
timeFrame: From date of randomization up to Month 15
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
timeFrame: Baseline up to Month 15
Other outcomes:
Locations:
city: Bullhead City
country: United States
state: Arizona
city: Tuscon
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Escondido
country: United States
state: California
city: Glendale
country: United States
state: California
city: Imperial
country: United States
state: California
city: Long Beach
country: United States
state: California
city: National City
country: United States
state: California
city: Oakland
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Bernadino
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Fran Cisco
country: United States
state: California
city: New Britain
country: United States
state: Connecticut
city: New London
country: United States
state: Connecticut
city: Leesburg
country: United States
state: Florida
city: Miami Gardens
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Naperville
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Witchita
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Flowood
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Paramus
country: United States
state: New Jersey
city: Willingboro
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Willoughby
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Desoto
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Wharton
country: United States
state: Texas
city: Bothell
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Rio Piedras
country: Puerto Rico
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.