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N/A N=15 Treatment

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

Metabolic Evaluation · Cardiac Complications

Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework — 180.60; 37.60; 88.80; 132 mg/dl

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Alpha Lipoic Acid (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Messina
Primary completion
Jun 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework
180.60; 37.60; 88.80; 132
SECONDARY
Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS)
74.80

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.

Eligibility Criteria

Inclusion Criteria

  • DSM-5 criteria for schizophrenia,
  • aged between 18 and 60 years old
  • in stable atypical antipsychotic monotherapy (clozapine, olanzapine, quetiapine, or risperidone) for least 3 months.

Exclusion Criteria

  • treatment with more than one atypical antipsychotic, current treatment with insulin/oral hypoglycaemic/lipid-lowering agents
  • significant concomitant medical pathologies
  • organic brain disorders
  • history of alcohol or substance dependence (excluding nicotine)
  • dementia
  • mental retardation
  • pregnancy/breastfeeding.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06787781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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