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

NCT ID: NCT06787781

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alpha Lipoid Acid

Subject with schizophrenia administrated with ALA

Group Type: EXPERIMENTAL

Alpha Lipoic Acid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Messina

OTHER

Sponsor Role: lead

Responsible Party

Fiammetta Iannuzzo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Messina

Messina, , Italy

Countries

Italy

References

Iannuzzo F, Basile GA, Campolo D, Genovese G, Pandolfo G, Giunta L, Ruggeri D, Di Benedetto A, Bruno A. Metabolic and clinical effect of alpha-lipoic acid administration in schizophrenic subjects stabilized with atypical antipsychotics: A 12-week, open-label, uncontrolled study. Curr Res Pharmacol Drug Discov. 2022 Jun 28;3:100116. doi: 10.1016/j.crphar.2022.100116. eCollection 2022.

Reference Type: RESULT

PMID: 35992380 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

alphalipoic1

Identifier Type: -

Identifier Source: org_study_id