Investigation of alpha-lipoic acid supplementation in patients with schizophrenia

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613000982718
• Date of registration: 03/09/2013
• Prospective Registration: No
• Primary sponsor: University of Belgrade, Faculty of Pharmacy
• Public title: Investigation of alpha-lipoic acid supplementation in patients with schizophrenia
• Scientific title: Investigation of alpha-lipoic acid supplementation on oxidative stress parameters in patients with schizophrenia
• Date of first enrolment: 21/04/2011
• Target sample size: 80
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12613000982718.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Assignment: Other;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Serbia and Montenegro

Contacts

• Name: Miss Bojana Vidovic

• Name: Miss Bojana Vidovic

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Schizophrenia

Schizophrenia;Metabolic sindrome;Cardiovascular disease;
Schizophrenia
Metabolic sindrome
Cardiovascular disease

Intervention(s)

This study will evaluate the effect of alpha lipoic acid (LA) in patients with schizophrenia treated with antipsychotics drugs. In this open label, interventional study we will investigate LA effects (capsule with 500 mg LA, once day 30 min before meals for 90 days) on oxidative stress markers and antioxidative defence in patients with schizophrenia and compared to healthy controls. We hypothesize that LA will effects on increased oxidative stress in schizophrenia, as well as improve some metabolic risk factors, that are resulting in side effects of antipsychotic use. Compliance measured through the number of returned capsules.

Primary Outcome(s)

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(s)

Effects of alpha-lipoic acid supplementation on metabolic risk factors
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.
Systolic and diastolic blood pressures were measured with a standard mercury sphygmomanometer
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. ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

University of Belgrade Faculty of Pharmacy

Ethics review

Status: Approved
Approval date:
Contact:

The Ethical Committee of the Clinical Centre of Serbia