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

Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects Stabilized With Atypical Antipsychotics: A 12-week, Open-label, Uncontrolled Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06787781

Enrollment

Registered

2025-01-22

Start date

2021-06-01

Completion date

2021-12-31

Last updated

2025-03-27

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

Conditions

Cardiac Complications, Metabolic Evaluation

Keywords

alphalipoic acid, schizophrenia

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.

Interventions

DRUGAlpha Lipoic Acid

ALA was administrated in capsules at a xed oral daily dose of 600 mg for the entire duration of the study in addition to the atypical antipsychotic therapy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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+

Other

Measure	Time frame	Description
Assessing the Effect of ALA on the Blood Parameters: Electrocardiography	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported	QTc interval
Assessing the Effect of ALA on BODY MASS INDEX	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported	body mass index
Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported	alanineaminotransferase (ALT), aspartate aminotransferase (AST), gammaglutamyl transferase (γGT), creatine phosphokinase (CPK)
Assessing the Effect of ALA on Prolactinemia	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported	prolactinemia
Assessing the Effect of ALA on Blood Pressure	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported	systolic and diastolic blood pressure
Assessing the Effect of ALA on the Blood Parameters: Renal Framework	Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported	Creatinine, Azotemia

Countries

Italy

Participant flow

Pre-assignment details

Patients who met DSM-5 criteria for schizophrenia, aged between 18 and 60 years old in stable atypical antipsychotic monotherapy (clozapine, olanza- pine, quetiapine, or risperidone) for least 3 months.

Participants by arm

Arm	Count
AlphaLipoidAcid Group Subject with schizophrenia administrated with ALA	15
Total	15

Baseline characteristics

Characteristic	AlphaLipoidAcid Group
Age, Continuous	44.60 years STANDARD_DEVIATION 11.16
ALT	28.80 U/L STANDARD_DEVIATION 12.06
AST	23.20 U/L STANDARD_DEVIATION 7.16
azotemia	26.60 mg/dl STANDARD_DEVIATION 4.14
Body massindex	32.18 kg/m2 STANDARD_DEVIATION 5.99
Body weight	95.80 kg STANDARD_DEVIATION 19.13
CPK	203.40 U/L STANDARD_DEVIATION 177.13
creatinine	.86 mg/dl STANDARD_DEVIATION 0.17
Diastolic blood pressure	82 mmHg STANDARD_DEVIATION 15.49
gammaGT	18.20 U/L STANDARD_DEVIATION 7.06
Glucose	105.40 mg/dl STANDARD_DEVIATION 14.05
glycated haemoglobin	5.20 percentage STANDARD_DEVIATION 0.53
HDL	38.8 mg/dl STANDARD_DEVIATION 6.74
LDL	108.80 mg/dl STANDARD_DEVIATION 33.93
prolactinemia	389.76 μUl/ml STANDARD_DEVIATION 405.65
Qtc	422.80 msec STANDARD_DEVIATION 17.11
Race/Ethnicity, Customized White	15 Participants
Region of Enrollment Italy	15 Participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	11 Participants
Systolic blood pressure	137 mmHg STANDARD_DEVIATION 22.01
total cholesterol	177.20 mg/dl STANDARD_DEVIATION 39.62
Total score at the PANSS (Positive and Negative Syndrome Scale)	72.80 units on a scale STANDARD_DEVIATION 26.64
Triglycerides	110.60 mg/dl STANDARD_DEVIATION 57.01

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 15
other Total, other adverse events	0 / 15
serious Total, serious adverse events	0 / 15

Outcome results

Primary

Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework

Assessment of metabolic parameters: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), trigycerides, glucose