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Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects Stabilized With Atypical Antipsychotics: A 12-week, Open-label, Uncontrolled Study
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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
University of Messina
Messina, Italy
Start Date
June 1, 2021
Primary Completion Date
June 1, 2021
Completion Date
December 31, 2021
Last Updated
March 27, 2025
15
ACTUAL participants
Alpha Lipoic Acid
DRUG
Lead Sponsor
University of Messina
NCT06948266
NCT04989270
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