Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
- Disease/Condition
- Schizophrenia
- Drug/Device/Intervention
- Aripiprazole
- Study type
- Interventional
- Intervention type
- drug
- Primary sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Phase
- Phase 4
- Start date
- Mar 14, 2024
- End date
- Sep 30, 2025
- Enrollment
- 60 participants
Change in Mitochondrial respiratory chain complex I activity
Schizophrenia is a serious mental disorder with a global prevalence of 1%. The main cause of
 this condition is dysfunction in the signaling of neurotransmitters dopamine, serotonin,
 glutamate and Gamma-aminobutyric acid .According to recent research, a disturbed cellular
 energy state caused by mitochondrial dysfunction is thought to be a factor in the development
 of schizophrenia.
 
 The aim of the treatment of schizophrenia is to reduce symptoms and is mainly based on the
 monoamine hypothesis. Atypical antipsychotics are the first-line of treatment.
 
 Certain typical and atypical antipsychotic medications have been shown in prior preclinical
 research to decrease mitochondrial respiratory chain complex I activity. In contrast to
 individuals who were drug-naive, Casademont et al. found a significant decrease in complex I
 activity with haloperidol and risperidone in one cross-sectional observational study. Also,
 there is evidence suggesting that mitochondrial dysfunction is linked to the extrapyramidal
 side effects seen with antipsychotics.
 
 To date, there are no randomized controlled trials that assess the effect of these drugs on
 mitochondrial functions. Hence, the present randomized controlled trial has been planned to
 evaluate and compare the clinical and biochemical markers of mitochondrial dysfunction in
 schizophrenia patients treated with the atypical antipsychotics risperidone and aripiprazole.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06236451
- Type
- Non-Device Trial
Access comprehensive clinical trial information for NCT06236451 through Pure Global AI's free database. This Phase 4 trial is sponsored by All India Institute of Medical Sciences, Bhubaneswar and is currently Not yet recruiting. The study focuses on Schizophrenia. Target enrollment is 60 participants.
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