Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia

Phase 4

Recruiting

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole; Drug: Risperidone

• Registration Number: NCT06236451
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Brief 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 develo...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-01
• Study Start: 2024-04-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aripiprazole group	Aripiprazole	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.
Risperidone group	Risperidone	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.

Primary Outcome Measures

Name	Time	Method
Change in Mitochondrial respiratory chain complex I activity	12 weeks	Mitochondrial respiratory chain complex I activity will be measured in platelets using a commercially available ELISA (enzyme-linked immunosorbent assay) kit at baseline and at 12 weeks of follow-up.

Secondary Outcome Measures

Name	Time	Method
Change in Newcastle Mitochondrial Disease Adult Scale (NMDAS) scores	12 weeks	Newcastle Mitochondrial Disease Adult Scale (NMDAS) scoring of all patients will be assessed at baseline and at 12 weeks of follow-up. The NMDAS offers a range of 0 to 5 points for each question. The results from each of the first three sections' questions are added together to determine each section's score. The more severe the ailment, the higher the score...
Change in Positive and Negative Syndrome Scale (PANSS) scores	12 weeks	Positive and Negative Syndrome Scale (PANSS) scoring will be done at baseline and at 12 weeks follow-up. Out of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale. The scores for these scales are arrived at by summation of ratings across component items. Therefore, the p...
Responder rate	12 weeks	A patient with a reduction of Positive and Negative Syndrome Scale (PANSS) scores by ≥50% from baseline will be considered a 'responder'..
Change in Serum pyruvate	12 weeks	Serum pyruvate will be measured using spectrophotometry at baseline and at 12 weeks follow up.
Change in Serum lactate	12 weeks	Serum lactate will be measured using spectrophotometry at baseline and at 12 weeks follow up
Change in Serum creatine kinase	12 weeks	Serum creatine kinase will be measured using autoanalyzer at baseline and at 12 weeks

Trial Locations

Locations (1)

All India Institute of Medical Sciences (AIIMS); 🇮🇳 Bhubaneswar, Odisha, India