A Study of Paliperidone Palmitate 6-Month Formulation

Summary

The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).

Timeline

Start

2017-11-20

Primary completion

2020-05-08

Completion

2020-05-08

Publications

• Correll CU, Johnston KL, Turkoz I, Kutch M, Knight RK, Doring M, Sajatovic M. Comparing two transitioning strategies to paliperidone palmitate once-every-6-months. CNS Spectr. 2024 Dec;29(6):633-639. doi: 10.1017/S1092852924000476. Epub 2024 Nov 8.
• Richarz U, Han J, Bai YM, Yu-Hai Chen E, Chung YC, Jhanwar VG, Kim SW, Sulaiman AH, Knight K, Gopal S. Efficacy and safety of paliperidone palmitate 6-monthly long-acting injectable in reduction of relapses in patients with schizophrenia: An Asian subgroup analysis of phase 3, randomized study. Medicine (Baltimore). 2023 Aug 25;102(34):e34623. doi: 10.1097/MD.0000000000034623.
• Najarian D, Turkoz I, Knight RK, Galderisi S, Lamaison HF, Zalitacz P, Aravind S, Richarz U. Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia. Int J Neuropsychopharmacol. 2023 Aug 29;26(8):537-544. doi: 10.1093/ijnp/pyad028.
• Najarian D, Sanga P, Wang S, Lim P, Singh A, Robertson MJ, Cohen K, Schotte A, Milz R, Venkatasubramanian R, T'Jollyn H, Walling DP, Galderisi S, Gopal S. A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia. Int J Neuropsychopharmacol. 2022 Mar 17;25(3):238-251. doi: 10.1093/ijnp/pyab071.

Drugs

Indications