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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha Lipoid Acid | Experimental | Subject with schizophrenia administrated with ALA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha Lipoic Acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
| Measure | Description | Time Frame |
|---|---|---|
| Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS) | 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+ |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework | alanineaminotransferase (ALT), aspartate aminotransferase (AST), gammaglutamyl transferase (γGT), creatine phosphokinase (CPK) | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
| Assessing the Effect of ALA on the Blood Parameters: Renal Framework |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Messina | Messina | 98122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35992380 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | AlphaLipoicAcid Group | Subject with schizophrenia administrated with ALA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AlphaLipoidAcid Group | Subject with schizophrenia administrated with ALA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | mg/dl | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
|
|
From enrollment to the end of treatment at 12 weeks
No patient presented neither adverse effects nor undesirable change in the safety parameters
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alpha Lipoic Acid | Subject with schizophrenia administrated with ALA Alpha 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. |
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The small sample size, the lack of a comparative treatment, and the uneven distribution between sexes. Additionally, the length of the study was relatively short and thus it was not possible to assess the long-term effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Fiammetta Iannuzzo | university of messina | 327 628 4688 | fiannuzzo@unime.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2021 | Mar 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
Creatinine, Azotemia |
| Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
| Assessing the Effect of ALA on the Blood Parameters: Electrocardiography | QTc interval | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
| Assessing the Effect of ALA on BODY MASS INDEX | body mass index | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
| Assessing the Effect of ALA on Blood Pressure | systolic and diastolic blood pressure | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
| Assessing the Effect of ALA on Prolactinemia | prolactinemia | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Body massindex | Mean | Standard Deviation | kg/m2 |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Qtc | Mean | Standard Deviation | msec |
|
| Triglycerides | Mean | Standard Deviation | mg/dl |
|
| total cholesterol | Mean | Standard Deviation | mg/dl |
|
| HDL | Mean | Standard Deviation | mg/dl |
|
| LDL | Mean | Standard Deviation | mg/dl |
|
| Glucose | Mean | Standard Deviation | mg/dl |
|
| glycated haemoglobin | Mean | Standard Deviation | percentage |
|
| ALT | Mean | Standard Deviation | U/L |
|
| AST | Mean | Standard Deviation | U/L |
|
| gammaGT | Mean | Standard Deviation | U/L |
|
| CPK | Mean | Standard Deviation | U/L |
|
| creatinine | Mean | Standard Deviation | mg/dl |
|
| azotemia | Mean | Standard Deviation | mg/dl |
|
| prolactinemia | Mean | Standard Deviation | μUl/ml |
|
| Total score at the PANSS (Positive and Negative Syndrome Scale) | 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 | Mean | Standard Deviation | units on a scale |
|
|
| Secondary | Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS) | 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+ | Posted | Mean | Standard Deviation | score on a scale | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
|
|
|
| Other Pre-specified | Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework | alanineaminotransferase (ALT), aspartate aminotransferase (AST), gammaglutamyl transferase (γGT), creatine phosphokinase (CPK) | Posted | Mean | Standard Deviation | U/L | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
|
|
|
| Other Pre-specified | Assessing the Effect of ALA on the Blood Parameters: Renal Framework | Creatinine, Azotemia | Posted | Mean | Standard Deviation | mg/dl | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
|
|
|
| Other Pre-specified | Assessing the Effect of ALA on the Blood Parameters: Electrocardiography | QTc interval | Posted | Mean | Standard Deviation | msec | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
|
|
|
| Other Pre-specified | Assessing the Effect of ALA on BODY MASS INDEX | body mass index | Posted | Mean | Standard Deviation | kg/m2 | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
|
|
|
| Other Pre-specified | Assessing the Effect of ALA on Blood Pressure | systolic and diastolic blood pressure | Posted | Mean | Standard Deviation | mmg Hg | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
|
|
|
| Other Pre-specified | Assessing the Effect of ALA on Prolactinemia | prolactinemia | Posted | Mean | Standard Deviation | μUl/ml | Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |
|
| CPK |
|