CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Aripiprazole +1 moredrug
Likely dose
Aripiprazole 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06236451
NCT06236451Phase 4Completed

A Randomized Controlled Trial to Evaluate Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia

All India Institute of Medical Sciences, Bhubaneswar·interventional·Posted Feb 1, 2024·Updated Nov 25, 2025

In Brief

A Phase 4 clinical trial evaluating Aripiprazole and Risperidone for Schizophrenia. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedFeb 1, 2024
Enrollment StartApr 5, 2024
Primary CompletionNov 3, 2025
Study CompletionNov 12, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 2.4 years ago

Interventions

Aripiprazoledrug

Aripiprazole will be started at dose of 10 mg/day and increased to a stable dose of 20 mg/day over 2-3 weeks and will be continued till 12 weeks.

Risperidonedrug

Risperidone will be started at dose of 2 mg/day and increased to a stable dose of 6 mg/day over 2-3 weeks and continued till 12 weeks.