Dataset Information

Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system.

ABSTRACT:

Objective

To 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 design

An open-label, prospective feasibility study.

Setting/participants

33 adult patients with schizophrenia were enrolled at 3 sites across Rwanda.

Interventions

The 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.

Results

This 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.

Conclusions

This 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.

SUBMITTER: Alphs L

PROVIDER: S-EPMC10124215 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system.

Alphs Larry L Turkoz Ibrahim I Smith-Swintosky Virginia V Keenan Alexander A Abraham Emily E Schotte Alain A Hooker Eileen E Damascene Iyamuremye Jean J Kayiteshonga Yvonne Y Bizoza Rutakayile R Mancevski Branislav B

BMJ open 20230418 4

<h4>Objective</h4>To 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.<h4>Study design</h4>An open-label, prospective feasibility study.<h4>Setting/participants</h4>33 adult patients with schizophrenia were enrolled at 3 sites across Rwanda.<h4>In ...[more]

PMID: 37072361

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Dataset Information

Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system.

Objective

Study design

Setting/participants

Interventions

Primary and secondary outcome measures

Results

Conclusions

Trial registration number

Publications

Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system.

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