BMJ Open · 11 authors, 6 centres
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This open-label feasibility study enrolled 33 adults with schizophrenia across three Rwandan sites to evaluate the practicality of conducting a larger trial of paliperidone palmitate long-acting injectables. The study was terminated early by the sponsor due to Good Clinical Practice and regulatory issues, though all identified limitations were deemed surmountable.
This open-label, prospective feasibility study enrolled 33 adults with schizophrenia at 3 sites in Rwanda to evaluate whether a large clinical trial of paliperidone palmitate long-acting injectables (PP1M and PP3M) could be conducted within the Rwandan mental healthcare system. The study was terminated early by the sponsor because certain aspects of conduct needed to be addressed to maintain Good Clinical Practice requirements and meet regulatory standards. Twelve participants (36.4%) reported at least one treatment-emergent adverse event, and one participant (3.0%) experienced a serious adverse event of hyperglycaemia during the maintenance phase requiring hospitalisation and treatment discontinuation. Adverse events were transient and consistent with prior studies. The study identified areas for improvement in governance, infrastructure, procedures, budget, and assessments, though none were considered insurmountable.
