Investigating mitochondrial dysfunction in schizophrenia patients treated with atypical antipsychotics
Official title: A Randomized Controlled Trial to Evaluate Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
Run by All India Institute of Medical Sciences, Bhubaneswar · NCT06236451 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing how two antipsychotic medications, aripiprazole and risperidone, affect the energy-producing parts of cells in people with schizophrenia who haven't taken these drugs recently.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Locations | 1 site (Bhubaneswar, Odisha) |
| Trial ID | NCT06236451 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include treatment-naive patients aged 18 to 60 who meet the DSM-5 criteria for schizophrenia.
✕Probably not a fit
Patients with other psychiatric disorders, known mitochondrial disorders, or significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to explore the impact of atypical antipsychotic medications, specifically aripiprazole and risperidone, on mitochondrial function in patients diagnosed with schizophrenia. It focuses on treatment-naive individuals or those who have not taken antipsychotic drugs for at least four weeks prior to recruitment. The research will assess mitochondrial respiratory chain complex I activity to understand its role in the pathophysiology of schizophrenia and the effects of these medications. The study is conducted at the All India Institute of Medical Sciences in Bhubaneswar, Odisha.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for schizophrenia by addressing mitochondrial dysfunction.
How similar studies have gone: Previous studies have indicated a link between antipsychotic medications and mitochondrial dysfunction, suggesting this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients diagnosed with other psychiatric disorders including schizoaffective disorder or schizophrenia with somatoform disorders. * Highly agitated patients who need immediate indoor-based treatment. * 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. * Pregnant or lactating mothers.
Where it's running
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All India Institute of Medical Sciences (AIIMS)
Bhubaneswar, Odisha, India Recruiting
Study contacts
- Study coordinator: Rituparna Maiti, MD
- Email: pharm_rituparna@aiimsbhubaneswar.edu.in
- Phone: 9438884191
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.