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Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia - Trial NCT06236451

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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NCT06236451
Phase 4
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06236451
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Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
A Randomized Controlled Trial to Evaluate Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia

Study Focus

Schizophrenia

Aripiprazole

Interventional

drug

Sponsor & Location

All India Institute of Medical Sciences, Bhubaneswar

Timeline & Enrollment

Phase 4

Mar 14, 2024

Sep 30, 2025

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

Schizophrenia
Simple schizophrenia
Schizophrenia, unspecified
Other schizophrenia
Paranoid schizophrenia

Data Source

ClinicalTrials.gov

NCT06236451

Non-Device Trial