Specific Learning DisabilitySLDNCT07240142
Neurotransmitter Levels in Children With Specific Learning Disorder
A study testing Blood Product and Elisa test in people with Specific Learning Disability and Healthy (Controls), run by Dilara Ulger Ozbek at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial was to measure how specific neurotransmitter levels in children with Specific Learning Disorder (SLD) change compared to controls. The relationship between these markers and the measured markers will be determined both theoretically and experimentally using various neuropsychological… Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Learning Disability, Healthy (Controls)
- What is being tested?
- Blood Product and Elisa test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2019to 16 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Study group: no additional mental disorder except a specific learning disability,
- The control group had no mental illness.
- Having no head injury or neurological illness for all groups.
- There is no drug that might possibly alter cognitive functions for all populations.
Who cannot join
- The study group had a mental disease other than a specific learning disability and ADHD.
- The control group had any mental condition.
- Having a head injury or neurological illness in all categories.
- Using drugs that may impair cognitive functioning in all groups those with additional diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Central, 58146
About this study
Official title: Biochemical and Docking Evidence of Neurotransmitter Dysregulation in Specific Learning Disorder
The aim of this clinical trial was to measure how specific neurotransmitter levels in children with Specific Learning Disorder (SLD) change compared to controls. The relationship between these markers and the measured markers will be determined both theoretically and experimentally using various neuropsychological tests. The fundamental questions it aims to answer are
Did neurotransmitter levels increase or decrease in the patient group? Are the neurotransmitter levels measured in the neuropsychological tests related? Can the measured neurotransmitters be used to predict the disease?
Read more
Participants:
A single visit to the clinic, a blood sample, and neuropsychological tests will be administered on the same day.
Read the detailed description
The purpose of this investigation was to assess the levels in serum of key neurotransmitters and their precursors (glutamate, L-arginine, and nitric oxide) in children with SLD and also to integrate these biochemical results with molecular docking analyses of their interactions with phospholipase A2 (PLA2) and N-methyl D-aspartate receptors (NMDA), both of which play significant roles in learning function in these patients.
The research group consisted of 20 children aged 7-14 years who had been diagnosed with SLD using DSM-5 criteria, as well as 20 age-matched, gender-matched, and educationally matched healthy controls. The children in the study group underwent the Stroop Test [Total Error Scores, Total Time Scores, Total Correction] and the Wechsler Intelligence Scale for Children (WISC-IV) subtests, and the results were scored. The serum concentrations of glutamate, L-arginine, and nitric oxide (NO) were determined using ELISA. The diagnostic ability of the biomarkers was evaluated using ROC analysis. Additionally, the interactions of glutamate and L-arginine with the PLA2 enzyme and the NMDA receptor were examined using molecular docking analysis.
- Conditions
- Specific Learning Disability, Healthy (Controls)
- Being tested
- Blood Product, Elisa test
- Keywords
- Specific learning Disorder, Glutamate, L-arginine, nitric oxide, molecualr docking
- Medical subject headings
- Specific Learning Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood ProductProcedure or surgery
Collecting 5 ml blood samples from the left atrial vein, after that obtaining serum from it.
Elisa testOther
Measurement of glutamate, nitric oxide, and L-arginine concentrations in the blood samples obtained using an ELISA test kit.
| Study group | Role | What they receive |
|---|---|---|
| Collection of blood samples | Experimental | A 5 ml blood sample will be taken from the left arterial vein of the individuals in the study group, and serum will be obtained from it. The neurotransmitter concentrations specified in the serum samples will be measured with an ELISA test kit. Receives: Procedure: Blood Product; Other: Elisa test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesurment of serum neurotransmitters levels
Serum Glutamate Levels (measured in µmol/L by ELISA at baseline)
Serum L-Arginine Levels (measured in µmol/L by ELISA at baseline)
Serum Nitric Oxide (NO) Levels (measured in µmol/L by ELISA at baseline)
Measured: 6 months
Verbal Comprehension Index (VCI)
Change in Verbal Comprehension Index (VCI) score from baseline to 6 months.Points on a scale (range: 40-160; higher scores indicate better performance)
Measured: 6 month
Perceptual Reasoning Index (PRI)
Change in Perceptual Reasoning Index (PRI) score from baseline to 6 months. Change in Perceptual Reasoning Index (PRI) score from baseline to 6 months.
Measured: 6 months
Working Memory Index (WMI)
Change in Working Memory Index (WMI) score from baseline to 6 months. Points on a scale (range: 40-160; higher scores indicate better performance)
Measured: 6 months
Processing Speed Index (PSI)
Change in Processing Speed Index (PSI) score from baseline to 6 months. Points on a scale (range: 40-160; higher scores indicate better performance).
Measured: 6 months
Stroop Test Performance
Change in Stroop Test total errors, total time, and total corrections from baseline to 6 months.Seconds (for time) and number of errors/corrections; lower scores indicate better performance.
Measured: 6 months
Full Scale IQ (FSIQ)
Change in Full Scale IQ (FSIQ) score from baseline to 6 months.oints on a scale (range: 40-160; higher scores indicate better performance)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start22 Oct 2019
- Primary completion21 Oct 2020
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Learning DisabilityStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Blood sample collection
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilara Ulger Ozbek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilara Ulger Ozbek, Cumhuriyet University
- Investigators
- Dilara ULGER OZBEK, Dr., Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240142
- Sponsor's protocol ID
- SCÜ Child Psychiatry
- Acronym
- SLD
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical and Docking Evidence of Neurotransmitter Dysregulation in Specific Learning Disorder
- ClinicalTrials.gov ID
- NCT07240142
- Acronym / sponsor ID
- SLD / SCÜ Child Psychiatry
- Conditions
- Specific Learning Disability, Healthy (Controls)
- Keywords
- Specific learning Disorder, Glutamate, L-arginine, nitric oxide, molecualr docking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dilara Ulger OzbekUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial was to measure how specific neurotransmitter levels in children with Specific Learning Disorder (SLD) change compared to controls. The relationship between these markers and the measured markers will be determined both theoretically and experimentally using various neuropsychological tests. The fundamental questions it aims to answer are
Did neurotransmitter levels increase or decrease in the patient group? Are the neurotransmitter levels measured in the neuropsychological tests related? Can the measured neurotransmitters be used to predict the disease?
Participants:
A single visit to the clinic, a blood sample, and neuropsychological tests will be administered on the same day.
Detailed description
The purpose of this investigation was to assess the levels in serum of key neurotransmitters and their precursors (glutamate, L-arginine, and nitric oxide) in children with SLD and also to integrate these biochemical results with molecular docking analyses of their interactions with phospholipase A2 (PLA2) and N-methyl D-aspartate receptors (NMDA), both of which play significant roles in learning function in these patients.
The research group consisted of 20 children aged 7-14 years who had been diagnosed with SLD using DSM-5 criteria, as well as 20 age-matched, gender-matched, and educationally matched healthy controls. The children in the study group underwent the Stroop Test [Total Error Scores, Total Time Scores, Total Correction] and the Wechsler Intelligence Scale for Children (WISC-IV) subtests, and the results were scored. The serum concentrations of glutamate, L-arginine, and nitric oxide (NO) were determined using ELISA. The diagnostic ability of the biomarkers was evaluated using ROC analysis. Additionally, the interactions of glutamate and L-arginine with the PLA2 enzyme and the NMDA receptor were examined using molecular docking analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Blood sample collection
| Arm | Type | Receives |
|---|---|---|
| Collection of blood samples | Experimental | Procedure: Blood Product, Other: Elisa testA 5 ml blood sample will be taken from the left arterial vein of the individuals in the study group, and serum will be obtained from it. The neurotransmitter concentrations specified in the serum samples will be measured with an ELISA test kit. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Study group: no additional mental disorder except a specific learning disability,
- The control group had no mental illness.
- Having no head injury or neurological illness for all groups.
- There is no drug that might possibly alter cognitive functions for all populations.
Key exclusion criteria (4 listed)
- The study group had a mental disease other than a specific learning disability and ADHD.
- The control group had any mental condition.
- Having a head injury or neurological illness in all categories.
- Using drugs that may impair cognitive functioning in all groups those with additional diseases
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 |
|---|---|---|
| Blood ProductCollecting 5 ml blood samples from the left atrial vein, after that obtaining serum from it. | Procedure or surgery | Collection of blood samples |
| Elisa testMeasurement of glutamate, nitric oxide, and L-arginine concentrations in the blood samples obtained using an ELISA test kit. | Other | Collection of blood samples |
Primary outcome
Mesurment of serum neurotransmitters levels
Time frame: 6 months
Serum Glutamate Levels (measured in µmol/L by ELISA at baseline) Serum L-Arginine Levels (measured in µmol/L by ELISA at baseline) Serum Nitric Oxide (NO) Levels (measured in µmol/L by ELISA at baseline)
Verbal Comprehension Index (VCI)
Time frame: 6 month
Change in Verbal Comprehension Index (VCI) score from baseline to 6 months.Points on a scale (range: 40-160; higher scores indicate better performance)
Perceptual Reasoning Index (PRI)
Time frame: 6 months
Change in Perceptual Reasoning Index (PRI) score from baseline to 6 months. Change in Perceptual Reasoning Index (PRI) score from baseline to 6 months.
Working Memory Index (WMI)
Time frame: 6 months
Change in Working Memory Index (WMI) score from baseline to 6 months. Points on a scale (range: 40-160; higher scores indicate better performance)
Processing Speed Index (PSI)
Time frame: 6 months
Change in Processing Speed Index (PSI) score from baseline to 6 months. Points on a scale (range: 40-160; higher scores indicate better performance).
Stroop Test Performance
Time frame: 6 months
Change in Stroop Test total errors, total time, and total corrections from baseline to 6 months.Seconds (for time) and number of errors/corrections; lower scores indicate better performance.
Full Scale IQ (FSIQ)
Time frame: 6 months
Change in Full Scale IQ (FSIQ) score from baseline to 6 months.oints on a scale (range: 40-160; higher scores indicate better performance)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- 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.
Dilara ULGER OZBEK, Dr. study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Product and Elisa test in people with Specific Learning Disability and Healthy (Controls), run by Dilara Ulger Ozbek at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 20 Nov 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mesurment of serum neurotransmitters levels (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.