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

NCT06787781 | Completed Results DMC

• 1 other identifier: alphalipoic1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

alphalipoic acid; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework

  Assessment of metabolic parameters: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), trigycerides, glucose

  Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

Secondary Outcomes (1)

• Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS)

  Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

Other Outcomes (6)

• Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework

  Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

• Assessing the Effect of ALA on the Blood Parameters: Renal Framework

  Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

• Assessing the Effect of ALA on the Blood Parameters: Electrocardiography

  Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

Study Arms (1)

Alpha Lipoid Acid

EXPERIMENTAL

Subject with schizophrenia administrated with ALA

Drug: Alpha Lipoic Acid

Interventions

Alpha Lipoic Acid 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.

Alpha Lipoid Acid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University of Messina

Messina, 98122, Italy

Location

Related Publications (1)

• 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.

  PMID: 35992380 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Limitations and Caveats

The small sample size, the lack of a comparative treatment, and the uneven distribution between sexes. Additionally, the length of the study was relatively short and thus it was not possible to assess the long-term effects.

Results Point of Contact

• Title: Dr Fiammetta Iannuzzo
• Organization: university of messina

fiannuzzo@unime.it

327 628 4688

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: January 22, 2025
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: December 31, 2021
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)