Mitochondrial dysfunction and disrupted cerebral energy metabolism have been increasingly linked to the pathophysiology of schizophrenia. Preclinical studies suggest that certain atypical antipsychotics may exacerbate mitochondrial dysfunction by inhibiting respiratory complex I, contributing to adverse effects. Risperidone, a dopamine D2/serotonin 5-HT2 antagonist, and aripiprazole, a partial dopamine D2 agonist, were selected because of their contrasting pharmacological profiles and reported differential effects on mitochondrial complex I activity. Despite these findings, the clinical implications remain poorly understood. This randomised controlled trial aims to evaluate and compare the biochemical and clinical effects of risperidone and aripiprazole on mitochondrial dysfunction in patients with schizophrenia.

In this randomised, open-label, parallel-arm clinical trial, 60 patients with schizophrenia who were drug-naïve or had not taken any antipsychotic drugs for at least 4 weeks before recruitment were randomly assigned to risperidone or aripiprazole treatment for 12 weeks, with inclusion of an additional group of 30 healthy individuals for baseline comparisons. The primary outcome is the change in mitochondrial respiratory chain complex I concentration in platelets, and secondary outcomes include serum lactate, pyruvate, creatine kinase levels and Newcastle Mitochondrial Disease Adult Scale (NMDAS) scores. Clinical efficacy and safety are evaluated using the Positive and Negative Syndrome Scale (PANSS) and monitoring treatment-emergent adverse events. Intention-to-treat analysis will be done for all parameters using suitable statistical tools.

Ethical approval was obtained from the Institutional Ethics Committee and the study conformed to the provisions of the Declaration of Helsinki and ICMR’s national ethical guidelines for biomedical and health research involving human participants (2017). Written informed consent will be obtained from the legally authorised representative of the patients. Results will be disseminated through peer-reviewed publications and conferences to inform safer treatment strategies for schizophrenia.

NCT06236451.

Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.

This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.

Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.