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Investigation of alpha-lipoic acid supplementation in patients with schizophrenia

Investigation of alpha-lipoic acid supplementation on oxidative stress parameters in patients with schizophrenia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000982718
Enrollment
80
Registered
2013-09-03
Start date
2011-04-21
Completion date
2012-04-12
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Increasing evidence suggested that oxidative stress exists in schizophrenia. Oxidative stress also has been indicate to contribute to metabolic syndrome and related disorders, including diabetes and cardiovascular disease, which are higher prevalence in schizophrenia compared to general population. Alpha-lipoic acid is a naturally occurring compound that is synthesized in small amounts by humans. It is found in spinach, potatoes, broccoli, red meats and liver. Orally supply alpha-lipoic acid has potent antioxidant activity. Beside, quenching free radicals, there is evidence that alpha-lipoic acid lead to regeneration endogenous antioxidants such as vitamins C and E, and GSH. Alpha-lipoic acid has been reported to has beneficial effect in many disease associated with increased oxidative stress, which could be a consequence of either increased production of free radicals or reduced antioxidant defenses.We hypothesized that LA would effects on increased oxidative stress in schizophrenia, as well as improved some metabolic risk factors, that are resulting in side effects of antipsychotic use.

Interventions

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 metab

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.

Sponsors

University of Belgrade, Faculty of Pharmacy
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026