Metabolic EvaluationNCT06787781
Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects
A study testing Alpha Lipoic Acid in people with Metabolic Evaluation and Cardiac Complications, run by University of Messina at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Evaluation, Cardiac Complications
- What is being tested?
- Alpha Lipoic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Metabolic Evaluation, Cardiac Complications
- Being tested
- Alpha Lipoic Acid
- Keywords
- alphalipoic acid, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic AcidDrug
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 group | Role | What they receive |
|---|---|---|
| Alpha Lipoid Acid | Experimental | Subject with schizophrenia administrated with ALA Receives: Drug: Alpha Lipoic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Secondary outcomes (1)
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+
Measured: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Jun 2021
- Primary completion1 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiammetta Iannuzzo, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787781
- Sponsor's protocol ID
- alphalipoic1
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2024
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35992380
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06787781
- Acronym / sponsor ID
- alphalipoic1
- Conditions
- Metabolic Evaluation, Cardiac Complications
- Keywords
- alphalipoic acid, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha Lipoid Acid | Experimental | Drug: Alpha Lipoic AcidSubject with schizophrenia administrated with ALA |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Lipoic AcidALA 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. | Drug | Alpha Lipoid Acid |
Primary outcome
Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework
Time frame: 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
1 secondary outcome
Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS)
Time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35992380Iannuzzo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Lipoic Acid in people with Metabolic Evaluation and Cardiac Complications, run by University of Messina at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework (time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.