Investigation of alpha-lipoic acid supplementation in patients with schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia; Metabolic sindrome; Cardiovascular disease; Mental Health - Schizophrenia

• Registration Number: ACTRN12613000982718
• Lead Sponsor: niversity of Belgrade, Faculty of Pharmacy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

A ICD 10 diagnosis of schizophrenia
Ability to give assent
All patients on stable dose of antipsychotic drugs
Otherwise medically stable

Inclusion criteria for healthy controls were absence of any psychiatric and somatic disease.

Exclusion Criteria

History of substance abuse or dependence
Several medical disorders: severe head injury, seizure disorders diabetes, cancer, renal or liver diseases, pregnancy
Oral contraceptives, hormone replacement therapy, hypolipidemic drugs, any food supplements at least 30 days before and during the study.
Patients clinically unstable on current medication regimen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects of alpha-lipoic acid supplementation on oxidative stress (plasma superoxide anion levels, serum thiobarbituric acid-reacting substances concentrations, plasma advanced oxidation protein products levels, serum total oxidative status levels, serum proxidative-antioxidative balance levels) and antioxidative defence markers : plasma (superoxide dismutase) and erythrocyte antioxidant enzyme acitivities ( superoxide dismutase, glutathione peroxidase, catalase), total glutathione concentrations in erythrocytes, plasma total sulfhydryl groups, serum total antioxidant status, plasma PON1 actiivity[All measurements were done at the point of the study start, after 45 days of supplementation with LA, and after 90 days of supplementation. ]

Secondary Outcome Measures

Name	Time	Method
Effects of alpha-lipoic acid supplementation on metabolic risk factors<br>Anthropometric measurements: weight and height were measured using a calibrated stadiometer and a balance beam scale , % body fat (bioimpedance analysis), waist and hip circumference were measured with a flexible tape.<br>Systolic and diastolic blood pressures were measured with a standard mercury sphygmomanometer<br>Laboratory analysis: plasma fasting glucose level and serum lipid status parameters [total cholesterol (t-C), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), triglycerides (TG)][All measurements were done at the point of the study start, after 45 days of supplementation with LA, and after 90 days of supplementation. ]