drugset / Trial / NCT01157351
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
RandomizedParallel-groupOpen-labelPrevention
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
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 |