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

SUBMITTER: Alphs L 

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

REPOSITORIES: biostudies-literature