Trial Outcomes & Findings for Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects (NCT NCT06787781)

NCT ID: NCT06787781

Last Updated: 2025-03-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
• Results posted on: 2025-03-27

Participant Flow

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.

Participant milestones

Measure	AlphaLipoicAcid Group Subject with schizophrenia administrated with ALA
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	AlphaLipoidAcid Group n=15 Participants Subject with schizophrenia administrated with ALA
Age, Continuous	44.60 years STANDARD_DEVIATION 11.16 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants
Region of Enrollment Italy	15 Participants n=5 Participants
Body weight	95.80 kg STANDARD_DEVIATION 19.13 • n=5 Participants
Body massindex	32.18 kg/m2 STANDARD_DEVIATION 5.99 • n=5 Participants
Systolic blood pressure	137 mmHg STANDARD_DEVIATION 22.01 • n=5 Participants
Diastolic blood pressure	82 mmHg STANDARD_DEVIATION 15.49 • n=5 Participants
Qtc	422.80 msec STANDARD_DEVIATION 17.11 • n=5 Participants
Triglycerides	110.60 mg/dl STANDARD_DEVIATION 57.01 • n=5 Participants
total cholesterol	177.20 mg/dl STANDARD_DEVIATION 39.62 • n=5 Participants
HDL	38.8 mg/dl STANDARD_DEVIATION 6.74 • n=5 Participants
LDL	108.80 mg/dl STANDARD_DEVIATION 33.93 • n=5 Participants
Glucose	105.40 mg/dl STANDARD_DEVIATION 14.05 • n=5 Participants
glycated haemoglobin	5.20 percentage STANDARD_DEVIATION .53 • n=5 Participants
ALT	28.80 U/L STANDARD_DEVIATION 12.06 • n=5 Participants
AST	23.20 U/L STANDARD_DEVIATION 7.16 • n=5 Participants
gammaGT	18.20 U/L STANDARD_DEVIATION 7.06 • n=5 Participants
CPK	203.40 U/L STANDARD_DEVIATION 177.13 • n=5 Participants
creatinine	.86 mg/dl STANDARD_DEVIATION .17 • n=5 Participants
azotemia	26.60 mg/dl STANDARD_DEVIATION 4.14 • n=5 Participants
prolactinemia	389.76 μUl/ml STANDARD_DEVIATION 405.65 • n=5 Participants
Total score at the PANSS (Positive and Negative Syndrome Scale)	72.80 units on a scale STANDARD_DEVIATION 26.64 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	AlphaLipoidAcid Group n=15 Participants Subject with schizophrenia administrated with ALA
Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework total cholesterol	180.60 mg/dl Standard Deviation 39.93
Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework HDL	37.60 mg/dl Standard Deviation 7.56
Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework Glucose	88.80 mg/dl Standard Deviation 12.56
Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework Triglicerides	132 mg/dl Standard Deviation 78.55

SECONDARY outcome

Timeframe: 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+

Outcome measures

Measure	AlphaLipoidAcid Group n=15 Participants Subject with schizophrenia administrated with ALA
Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS)	74.80 score on a scale Standard Deviation 34.21

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Measure	AlphaLipoidAcid Group n=15 Participants Subject with schizophrenia administrated with ALA
Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework ALT	21.80 U/L Standard Deviation 9.76
Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework AST	17.80 U/L Standard Deviation 3.36
Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework γGT	15.60 U/L Standard Deviation 6.13
Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework CPK	84.20 U/L Standard Deviation 50.35

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

Creatinine, Azotemia

Outcome measures

Measure	AlphaLipoidAcid Group n=15 Participants Subject with schizophrenia administrated with ALA
Assessing the Effect of ALA on the Blood Parameters: Renal Framework creatinine	.88 mg/dl Standard Deviation .13
Assessing the Effect of ALA on the Blood Parameters: Renal Framework azotemia	30.80 mg/dl Standard Deviation 4.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

QTc interval

Outcome measures

Measure	AlphaLipoidAcid Group n=15 Participants Subject with schizophrenia administrated with ALA
Assessing the Effect of ALA on the Blood Parameters: Electrocardiography	408.80 msec Standard Deviation 21.74

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

body mass index

Outcome measures

Measure	AlphaLipoidAcid Group n=15 Participants Subject with schizophrenia administrated with ALA
Assessing the Effect of ALA on BODY MASS INDEX	32.84 kg/m2 Standard Deviation 5.63

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

systolic and diastolic blood pressure

Outcome measures

Measure	AlphaLipoidAcid Group n=15 Participants Subject with schizophrenia administrated with ALA
Assessing the Effect of ALA on Blood Pressure systolic blood pressure	128 mmg Hg Standard Deviation 18.07
Assessing the Effect of ALA on Blood Pressure diastolic blood pressure	84 mmg Hg Standard Deviation 14.68

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

prolactinemia

Outcome measures

Measure	AlphaLipoidAcid Group n=15 Participants Subject with schizophrenia administrated with ALA
Assessing the Effect of ALA on Prolactinemia	190.16 μUl/ml Standard Deviation 196.75

Adverse Events

Alpha Lipoic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Fiammetta Iannuzzo

university of messina

Phone: 327 628 4688

Email: fiannuzzo@unime.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place