N/A
N=15
Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects
Metabolic Evaluation · Cardiac Complications
Bottom Line
View on ClinicalTrials.gov: NCT06787781 ↗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
| Outcome | Result | p-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.
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.