Clinical trial NCT06787781: Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects
Official title: Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects Stabilized With Atypical Antipsychotics: A 12-week, Open-label, Uncontrolled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Evaluation
Cardiac Complications
Keywords: alphalipoic acid
schizophrenia
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework
timeFrame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Secondary outcomes:
measure: Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS)
timeFrame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Other outcomes:
measure: Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework
timeFrame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
measure: Assessing the Effect of ALA on the Blood Parameters: Renal Framework
timeFrame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
measure: Assessing the Effect of ALA on the Blood Parameters: Electrocardiography
timeFrame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
measure: Assessing the Effect of ALA on BODY MASS INDEX
timeFrame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
measure: Assessing the Effect of ALA on Blood Pressure
timeFrame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
measure: Assessing the Effect of ALA on Prolactinemia
timeFrame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
References:
citation: 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.