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

Outcome

Met primary endpoint

paper thus meeting noninferiority criteria (95% CI lower bound is larger than the pre-specified noninferiority margin of -10%). PMID 34791283 ↗

release “Data showed non-inferior efficacy of PP6M compared to paliperidone palmitate 3-month (PP3M) on the primary endpoint of time to relapse” jnj.com ↗

release “The results showed non-inferiority of PP6M compared with PP3M on the primary endpoint of time to first relapse” jnj.com ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	paliperidone palmitate	Unknown	350 mg	Intramuscular
Subject	paliperidone palmitate	Unknown	525 mg	Intramuscular
Subject	paliperidone palmitate	Unknown	700 mg	Intramuscular
Subject	paliperidone palmitate	Unknown	1000 mg	Intramuscular
Background	PP1M	Unknown	50 mg	Intramuscular
Background	PP1M	Unknown	100 mg	Intramuscular
Background	PP1M	Unknown	150 mg	Intramuscular

Indications