Investigating mitochondrial dysfunction in schizophrenia patients treated with atypical antipsychotics
A Randomized Controlled Trial to Evaluate Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Locations | 1 site (Bhubaneswar, Odisha) |
| Trial ID | NCT06236451 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include treatment-naive patients aged 18 to 60 who meet the DSM-5 criteria for schizophrenia.
Not a fit: Patients with other psychiatric disorders, known mitochondrial disorders, or significant comorbidities may not benefit from this study.
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 performed: Previous studies have indicated a link between antipsychotic medications and mitochondrial dysfunction, suggesting this approach may yield valuable insights.
Eligibility criteria
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 this trial is running
Bhubaneswar, Odisha
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.