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

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.

Timeline

Start

2010-05

Primary completion

2013-12

Completion

2013-12

Outcome

Met primary endpoint

paper Paliperidone palmitate was associated with significant delay in time to first treatment failure versus oral antipsychotics PMID 25938474 ↗

paper hazard ratio, 1.43; 95% CI, 1.09-1.88; log rank P = .011 PMID 25938474 ↗

Publications

• Lopena OJ, Alphs LD, Sajatovic M, Turkoz I, Sun L, Johnston KL, Sliwa JK, Najarian DM, Starr HL. Earlier Use of Long-Acting Injectable Paliperidone Palmitate Versus Oral Antipsychotics in Patients With Schizophrenia: An Integrated Patient-Level Post Hoc Analysis. J Clin Psychiatry. 2023 Sep 25;84(6):23m14788. doi: 10.4088/JCP.23m14788.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aripiprazole	Other / unclassified	—	Oral
Comparator	Haloperidol	Other / unclassified	—	Oral
Comparator	Olanzapine	Small molecule	—	Oral
Subject	Paliperidone	Unknown	—	Oral
Comparator	Perphenazine	Small molecule	—	Oral
Comparator	Quetiapine	Small molecule	—	Oral
Comparator	Risperidone	Other / unclassified	—	Oral
Subject	paliperidone palmitate	Unknown	78 mg	Other
Subject	paliperidone palmitate	Unknown	117 mg	Other
Subject	paliperidone palmitate	Unknown	156 mg	Other
Subject	paliperidone palmitate	Unknown	234 mg	Other

Indications