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Evaluation of atypical antipsychotic-induced mitochondrial dysfunction in patients with schizophrenia: a randomised
Amiya Shaju1, Debadatta Mohapatra2, Biswa Ranjan Mishra2
1Pharmacology, All India Institute of Medical Sciences Bhubaneswar, Bhubaneswar, Odisha, India.
Introduction:
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.
Methods And Analysis:
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.
Ethics And Dissemination:
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.
Trial Registration Number:
NCT06236451.
Insights
This study compares risperidone and aripiprazole effects on mitochondrial function in schizophrenia patients. It investigates biochemical changes and clinical outcomes to inform safer antipsychotic strategies.
Area of Science:
- Neuroscience
- Biochemistry
- Psychiatry
Background:
- Mitochondrial dysfunction is implicated in schizophrenia pathophysiology.
- Atypical antipsychotics may worsen mitochondrial issues, particularly complex I inhibition.
- Risperidone and aripiprazole have different pharmacological profiles and potential effects on mitochondrial complex I.
Purpose of the Study:
- To compare the biochemical and clinical effects of risperidone and aripiprazole on mitochondrial dysfunction in schizophrenia patients.
- To evaluate changes in mitochondrial respiratory chain complex I concentration and related biochemical markers.
- To assess the clinical efficacy and safety of these antipsychotics in relation to mitochondrial function.
Main Methods:
- Randomised, open-label, parallel-arm trial with 60 schizophrenia patients and 30 healthy controls.
- 12-week treatment with either risperidone or aripiprazole.
- Primary outcome: change in platelet mitochondrial respiratory chain complex I concentration; secondary outcomes: serum lactate, pyruvate, creatine kinase, NMDAS, PANSS scores.
Main Results:
- The study is designed to evaluate changes in mitochondrial complex I concentration and related biochemical markers.
- Clinical efficacy will be assessed using the Positive and Negative Syndrome Scale (PANSS).
- Treatment-emergent adverse events will be monitored.
Conclusions:
- This trial aims to provide insights into the differential effects of risperidone and aripiprazole on mitochondrial function in schizophrenia.
- Findings may inform the development of safer and more effective treatment strategies for schizophrenia.
- Understanding these biochemical effects could lead to personalized antipsychotic selection.
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