NCT06236451CompletedPhase 4
Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
A Randomized Controlled Trial to Evaluate Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 24 Jan 2024
- Start date
- 5 Apr 2024
- Primary completion date
- 3 Nov 2025
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Diseases
- Schizophrenia
- NCT number
- NCT06236451
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 5 Apr 2024 to the primary completion date, 3 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients diagnosed with other psychiatric disorders including schizoaffective disorder or schizophrenia with somatoform disorders.
- Patients with known mitochondrial disorders (MELAS, LHON, Leigh syndrome, KearnsSayre syndrome, MERRF etc.)
- Patients with history of comorbidities like cardiovascular, renal, hepatic, neurological, respiratory or endocrinal diseases or malignancies.
- Patients with history of substance abuse.
Other
- Highly agitated patients who need immediate indoor-based treatment.
- Pregnant or lactating mothers.
Who the study is looking for
- Patients meeting the DSM-5 criteria for diagnosis of schizophrenia.
- Treatment naıv̈ e patients or patients who had not taken any antipsychotic drugs for at least 4 weeks before recruitment.
- Patients of either sex between the ages of 18 and 60 years.
- Legally authorized representative (LAR) of patients consenting to participate in the study by signing the informed consent form.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| All India Institute of Medical Sciences (AIIMS) Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.