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A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the
Dean Najarian1, Panna Sanga2, Steven Wang2
1Janssen Scientific Affairs, LLC, New Jersey, USA.
The International Journal of Neuropsychopharmacology
|November 18, 2021
Summary
Paliperidone palmitate 6-month (PP6M) injection is as effective as the 3-month formulation (PP3M) for preventing relapse in schizophrenia patients. Both long-acting injectable antipsychotics demonstrated similar safety profiles in this clinical trial.
Area of Science:
- Psychiatry
- Pharmacology
- Clinical Trials
Background:
- Schizophrenia is a chronic mental disorder requiring long-term treatment.
- Long-acting injectable antipsychotics offer an alternative to daily oral medication.
- Paliperidone palmitate formulations (PP1M, PP3M, PP6M) provide extended-release options.
Purpose of the Study:
- To compare the efficacy and safety of paliperidone palmitate 6-month (PP6M) versus paliperidone palmitate 3-month (PP3M) formulations.
- To evaluate PP6M as a twice-yearly dosing regimen for schizophrenia management.
- To assess the noninferiority of PP6M to PP3M in preventing relapse.
Main Methods:
- Double-blind, randomized, parallel-group study design.
- 1036 patients screened; 702 randomized to PP6M or PP3M after an open-label phase.
- 12-month treatment duration with efficacy and safety assessments.
Main Results:
- PP6M demonstrated noninferiority to PP3M in preventing relapse (difference: -2.9%, 95% CI: -6.8%, 1.1%).
- Relapse rates were 7.5% for PP6M and 4.9% for PP3M.
- Treatment-emergent adverse event incidences were similar between groups (62.1% for PP6M, 58.5% for PP3M).
Conclusions:
- The 6-month paliperidone palmitate formulation (PP6M) is effective and noninferior to the 3-month formulation (PP3M) for relapse prevention in schizophrenia.
- PP6M offers a viable twice-yearly treatment option for patients with schizophrenia.
- No new safety concerns were identified with the PP6M formulation.
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