NCT06236451

Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia

A Randomized Controlled Trial to Evaluate Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
All India Institute of Medical Sciences, Bhubaneswar·Phase 4·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Schizophrenia
Drug/Device/Intervention
Aripiprazole
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
All India Institute of Medical Sciences, Bhubaneswar
Timeline & enrollment
Phase
Phase 4
Start date
Mar 14, 2024
End date
Sep 30, 2025
Enrollment
60 participants
Primary outcome

Change in Mitochondrial respiratory chain complex I activity

Summary

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.

ICD-10 classifications
SchizophreniaSimple schizophreniaSchizophrenia, unspecifiedOther schizophreniaParanoid schizophrenia
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06236451
Type
Non-Device Trial
About this record

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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