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

Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects Stabilized With Atypical Antipsychotics: A 12-week, Open-label, Uncontrolled Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Complications; Metabolic Evaluation
• Intervention / Treatment: Drug: Alpha Lipoic Acid

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98122
    • University of Messina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alpha Lipoid Acid; Subject with schizophrenia administrated with ALA	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS)	The PANSS (Positive and Negative Syndrome Scale) is a widely used tool for measuring the severity of schizophrenia symptoms. It assesses positive symptoms, negative symptoms, and general psychopathology in individuals with schizophrenia or related disorders. Cut off score of the scale: Total score (range 30-210); severity range: severity ranges: Mild symptoms: ~58-75 Moderate symptoms: ~75-95 Marked symptoms: ~95-116 Severe symptoms: ~116+	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework	alanineaminotransferase (ALT), aspartate aminotransferase (AST), gammaglutamyl transferase (γGT), creatine phosphokinase (CPK)	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	Creatinine, Azotemia	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Assessing the Effect of ALA on the Blood Parameters: Electrocardiography	QTc interval	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Assessing the Effect of ALA on BODY MASS INDEX	body mass index	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Assessing the Effect of ALA on Blood Pressure	systolic and diastolic blood pressure	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Assessing the Effect of ALA on Prolactinemia	prolactinemia	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

Collaborators and Investigators

• Sponsor: University of Messina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: schizophrenia; alphalipoic acid
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Antioxidants; Protective Agents; Vitamin B Complex; Vitamins; Thioctic Acid
• Other Study ID Numbers: alphalipoic1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No