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

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Alpha Lipoid Acid	Alpha Lipoic Acid	Subject with schizophrenia administrated with ALA

Primary Outcome Measures

Name	Time	Method
Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported	Assessment of metabolic parameters: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), trigycerides, glucose

Secondary Outcome Measures

Name	Time	Method
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	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+