Trial reportBMJ open2023
Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system.
Trial report in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03713658 (A Pilot-Study in Rwandan Health Care Settings to Examine the Feasibility of a Large Pragmatic Clinical Study to Assess the Value of Paliperidone Palmitate in Rwanda), which is not on this map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pilot-Study in Rwandan Health Care Settings to Examine the Feasibility of a Large Pragmatic Clinical Study to Assess the Value of Paliperidone Palmitate in Rwanda
Who cites it
3 citing papers in PubMed, 1 citations in OpenAlex.
- Consenting practices to enhance comprehension in research involving individuals with schizophrenia and bipolar affective disorder in Uganda: a qualitative inquiry.BMC psychology · 2026Article
- Article
- Ethical challenges researchers encounter during the informed consent processes for research involving people with schizophrenia and bipolar affective disorder: a qualitative assessment.BMC medical ethics · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the feasibility of conducting a large clinical trial within the Rwandan mental healthcare system that would establish the safety, efficacy and benefit of paliperidone palmitate once-monthly (PP1M) and once-every-3-months (PP3M) long-acting injectable formulations in adults with schizophrenia. STUDY
designAn open-label, prospective feasibility study. SETTING/
participants33 adult patients with schizophrenia were enrolled at 3 sites across Rwanda.
interventionsThe study design included 3 phases of treatment: an oral run-in to establish tolerability to risperidone (1 week), lead-in treatment with flexibly dosed PP1M to identify a stable dose (17 weeks) and maintenance treatment with PP3M (24 weeks). PRIMARY AND SECONDARY OUTCOME MEASURES: Feasibility endpoints included compliance with governmental and institutional requirements, acceptable supply chain delivery and proper onsite administration of risperidone/PP1M/PP3M, adequate site infrastructure, adequate training of clinical staff and successful completion of study procedures and scales. A variety of study scales were administered to assess outcomes relevant to patients, caregivers, clinicians and payers in Rwanda and other resource-limited settings.
resultsThis study was terminated early by the sponsor because certain aspects of study conduct needed to be addressed to maintain Good Clinical Practice requirements and meet regulatory standards. Results identified areas for improvement in study execution, including study governance, site infrastructure, study preparation and conduct of procedures, study budget and study assessments. Despite the identification of areas in need of adjustment, none of these limitations were considered insurmountable.
conclusionsThis work was designed to strengthen global research in schizophrenia by building the capacity of researchers to prepare and conduct pharmaceutical trials in resource-limited settings. Although the study was ended early, modifications motivated by the results will facilitate the successful design and completion of more comprehensive studies, including an ongoing, follow-up interventional trial of PP1M/PP3M in a larger population of patients in Rwanda. TRIAL REGISTRATION NUMBER: NCT03713658.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.