NCT06787781

Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects

Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects Stabilized With Atypical Antipsychotics: A 12-week, Open-label, Uncontrolled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Messina · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The therapeutic use of ALA in schizophrenia has recently been investigated in human populations. A case series explored the effiacy of ALA as a novel agent to treat antipsychotic-induced obesity, at a dose of 1200 mg/d (range between 600 and 1800 mg/d); reporting the key effect to be a reduction in body weight and BMI after a 12-week treatment. In a pilot open-label trial, 100 mg/d of ALA was administrated as a general adjuvant to antipsychotics therapy, with no significant improvement in BMI, abdominal circumference, blood count, or liver enzymes. Finally, another study investigated the effects of 500 mg/d of ALA on plasma adiponectin levels, fasting glucose, and aspartate aminotransferase activity, with no significant effect on the metabolic parameters. Based on this background, ALA may be a potentially interesting therapeutic agent to improve the metabolic effects of atypical antipsychotics. The purpose of this study was to assess: (1) the efficacy of ALA on metabolic factors and (2) its safety and potential therapeutic effects in a sample of schizophrenic patients in stable therapy with atypical antipsychotics.

Conditions

• Metabolic Evaluation
• Cardiac Complications

Interventions

Type	Name	Description
DRUG	Alpha Lipoic Acid	ALA was administrated in capsules at a xed oral daily dose of 600 mg for the entire duration of the study in addition to the atypical antipsychotic therapy.

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-06-01
• Completion: 2021-12-31
• First posted: 2025-01-22
• Last updated: 2025-03-27
• Results posted: 2025-03-27

Locations

1 site across 1 country: Italy