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

U

University of Messina

Status

Completed

Conditions

Cardiac Complications
Metabolic Evaluation

Treatments

Drug: Alpha Lipoic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT06787781
alphalipoic1

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Alpha Lipoid Acid
Experimental group
Description:
Subject with schizophrenia administrated with ALA
Treatment:
Drug: Alpha Lipoic Acid

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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