Attention Deficit Hyperactivity Disorder (ADHD)PS-DHA-ADHDNCT07521449
Effects of Phosphatidylserine and DHA on Cognitive Performance in Children With ADHD
A study testing Phosphatidylserine-Omega3 and DHA Omega-3 in people with Attention Deficit Hyperactivity Disorder (ADHD) and ADHD, run by Çağlar Charles Daniel Jaicks at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of different phosphatidylserine (PS) formulations, with or without docosahexaenoic acid (DHA), on cognitive performance in children diagnosed with attention-deficit/hyperactivity disorder (ADHD) or presenting with clinically significant subthreshold ADHD symptoms. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD), ADHD
- What is being tested?
- Phosphatidylserine-Omega3 and DHA Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2023to 1 Jun 2025
- 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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 10-14 years
- Diagnosis of ADHD according to DSM-5 criteria or clinically significant subthreshold ADHD symptoms
- Medication-naïve status
- Ability to complete cognitive assessments (MOXO d-CPT and Stroop test)
- Informed consent obtained from parents or legal guardians
Who cannot join
- Presence of psychiatric disorders requiring pharmacological treatment (e.g., major depressive disorder, severe anxiety disorders, autism spectrum disorder)
- Neurological or sensory impairments affecting test performance
- Use of cognitive-enhancing supplements (e.g., omega-3, phosphatidylserine, citicoline) within the previous 8 weeks
- Severe ADHD requiring immediate pharmacological treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydin University, Department of Child and Adolescent Psychiatry, Istanbul, Turkey
Istanbul, Istanbul, 34295
About this study
Official title: Differential Cognitive Effects of DHA-Enriched and Standard Phosphatidylserine Formulations in Children With ADHD: A Randomized Placebo-Controlled Trial
This study aimed to evaluate the effects of different phosphatidylserine (PS) formulations, with or without docosahexaenoic acid (DHA), on cognitive performance in children diagnosed with attention-deficit/hyperactivity disorder (ADHD) or presenting with clinically significant subthreshold ADHD symptoms.
A total of 45 medication-naïve children aged 10-14 years were randomly assigned to one of four groups: placebo, PS capsule (PS + DHA), PS sachet (PS without DHA), or PS Plus capsule (higher-dose PS + DHA). The intervention period was eight weeks.
Cognitive performance was assessed at baseline and after the intervention using the MOXO continuous performance test and the Stroop test. The study aimed to compare the effects of different PS formulations on attention, impulsivity, hyperactivity, and executive function.
Read the detailed description
This prospective, randomized, placebo-controlled clinical trial was conducted to investigate the cognitive effects of phosphatidylserine-based nutritional supplementation in children with ADHD or clinically significant subthreshold ADHD symptoms.
Participants were medication-naïve children aged 10-14 years who were diagnosed based on DSM-5 criteria or clinical evaluation supported by standardized rating scales. Eligible participants were randomly assigned in a 1:1:1:1 ratio to one of four groups: placebo, PS capsule (100 mg phosphatidylserine + 17.78 mg DHA), PS sachet (117.78 mg phosphatidylserine without DHA), or PS Plus capsule (150 mg phosphatidylserine + 26.67 mg DHA).
All participants received their assigned intervention once daily for eight weeks. Cognitive outcomes were assessed using the MOXO continuous performance test (MOXO d-CPT), which evaluates attention, impulsivity, timing, and hyperactivity, and the Stroop test, which measures executive function, inhibitory control, and cognitive flexibility.
The primary objective of the study was to compare changes in cognitive performance across the different intervention groups. The study was conducted in a single-center clinical setting, and all assessments were performed under standardized conditions.
The findings were intended to provide insight into the dose- and formulation-dependent cognitive effects of phosphatidylserine supplementation, particularly in combination with DHA, in pediatric ADHD populations.
- Being tested
- Placebo, Phosphatidylserine-Omega3, DHA Omega-3
- Keywords
- Phosphatidylserine, DHA, Cognitive Function, Executive Function, MOXO Test, Stroop Test
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo formulation identical in appearance and administration to active supplements.
Phosphatidylserine-Omega3Dietary supplement
Also called Phosphatidylserine Capsule
Capsule containing 100 mg phosphatidylserine and 17.78 mg DHA administered once daily for 8 weeks.
Phosphatidylserine-Omega3Dietary supplement
Also called Phosphatidylserine Sachet
Sachet formulation containing 117.78 mg phosphatidylserine without DHA administered once daily for 8 weeks.
DHA Omega-3Dietary supplement
Also called Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks.
Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Participants received placebo once daily for 8 weeks. Receives: Other: Placebo |
| PS Capsule Group | Experimental | Participants received phosphatidylserine capsule with DHA once daily for 8 weeks. Receives: Dietary Supplement: Phosphatidylserine-Omega3 |
| PS Sachet Group | Experimental | Participants received phosphatidylserine sachet without DHA once daily for 8 weeks. Receives: Dietary Supplement: Phosphatidylserine-Omega3 |
| PS Plus Group | Experimental | Participants received higher-dose phosphatidylserine with DHA once daily for 8 weeks. Receives: Dietary Supplement: DHA Omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Attention and Executive Function Scores (MOXO and Stroop Tests)
Change from baseline to 8 weeks in cognitive performance assessed using the MOXO continuous performance test (attention, impulsivity, timing, and hyperactivity domains) and the Stroop test (reaction time, error rates, and correction counts).
Measured: Baseline and 8 weeks
Secondary outcomes (6)
Change in MOXO Attention Score
Change from baseline to 8 weeks in attention performance measured by MOXO d-CPT.
Measured: Baseline and 8 weeks
Change in MOXO Impulsivity Score
Change from baseline to 8 weeks in impulsivity measured by MOXO d-CPT.
Measured: Baseline and 8 weeks
Change in MOXO Hyperactivity Score
Change from baseline to 8 weeks in hyperactivity measured by MOXO d-CPT.
Measured: Baseline and 8 weeks
Change in Stroop Reaction Time
Change from baseline to 8 weeks in reaction time measured by the Stroop test.
Measured: Baseline and 8 weeks
Change in Stroop Error Scores
Change from baseline to 8 weeks in error rates measured by the Stroop test.
Measured: Baseline and 8 weeks
Change in Stroop Correction Counts
Change from baseline to 8 weeks in correction counts measured by the Stroop test.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start30 Dec 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of four parallel groups receiving placebo or different phosphatidylserine formulations, with or without DHA, and followed over an 8-week intervention period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çağlar Charles Daniel Jaicks
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Çağlar Charles Daniel Jaicks, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521449
- Sponsor's protocol ID
- PS-DHA-ADHD-2023
- Acronym
- PS-DHA-ADHD
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Cognitive Effects of DHA-Enriched and Standard Phosphatidylserine Formulations in Children With ADHD: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07521449
- Acronym / sponsor ID
- PS-DHA-ADHD / PS-DHA-ADHD-2023
- Keywords
- Phosphatidylserine, DHA, Cognitive Function, Executive Function, MOXO Test, Stroop Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Çağlar Charles Daniel JaicksUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 13 Apr 2026 (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.
This study aimed to evaluate the effects of different phosphatidylserine (PS) formulations, with or without docosahexaenoic acid (DHA), on cognitive performance in children diagnosed with attention-deficit/hyperactivity disorder (ADHD) or presenting with clinically significant subthreshold ADHD symptoms.
A total of 45 medication-naïve children aged 10-14 years were randomly assigned to one of four groups: placebo, PS capsule (PS + DHA), PS sachet (PS without DHA), or PS Plus capsule (higher-dose PS + DHA). The intervention period was eight weeks.
Cognitive performance was assessed at baseline and after the intervention using the MOXO continuous performance test and the Stroop test. The study aimed to compare the effects of different PS formulations on attention, impulsivity, hyperactivity, and executive function.
Detailed description
This prospective, randomized, placebo-controlled clinical trial was conducted to investigate the cognitive effects of phosphatidylserine-based nutritional supplementation in children with ADHD or clinically significant subthreshold ADHD symptoms.
Participants were medication-naïve children aged 10-14 years who were diagnosed based on DSM-5 criteria or clinical evaluation supported by standardized rating scales. Eligible participants were randomly assigned in a 1:1:1:1 ratio to one of four groups: placebo, PS capsule (100 mg phosphatidylserine + 17.78 mg DHA), PS sachet (117.78 mg phosphatidylserine without DHA), or PS Plus capsule (150 mg phosphatidylserine + 26.67 mg DHA).
All participants received their assigned intervention once daily for eight weeks. Cognitive outcomes were assessed using the MOXO continuous performance test (MOXO d-CPT), which evaluates attention, impulsivity, timing, and hyperactivity, and the Stroop test, which measures executive function, inhibitory control, and cognitive flexibility.
The primary objective of the study was to compare changes in cognitive performance across the different intervention groups. The study was conducted in a single-center clinical setting, and all assessments were performed under standardized conditions.
The findings were intended to provide insight into the dose- and formulation-dependent cognitive effects of phosphatidylserine supplementation, particularly in combination with DHA, in pediatric ADHD populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants were randomly assigned to one of four parallel groups receiving placebo or different phosphatidylserine formulations, with or without DHA, and followed over an 8-week intervention period.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: PlaceboParticipants received placebo once daily for 8 weeks. |
| PS Capsule Group | Experimental | Dietary Supplement: Phosphatidylserine-Omega3Participants received phosphatidylserine capsule with DHA once daily for 8 weeks. |
| PS Sachet Group | Experimental | Dietary Supplement: Phosphatidylserine-Omega3Participants received phosphatidylserine sachet without DHA once daily for 8 weeks. |
| PS Plus Group | Experimental | Dietary Supplement: DHA Omega-3Participants received higher-dose phosphatidylserine with DHA once daily for 8 weeks. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 10-14 years
- Diagnosis of ADHD according to DSM-5 criteria or clinically significant subthreshold ADHD symptoms
- Medication-naïve status
- Ability to complete cognitive assessments (MOXO d-CPT and Stroop test)
- Informed consent obtained from parents or legal guardians
Key exclusion criteria (4 listed)
- Presence of psychiatric disorders requiring pharmacological treatment (e.g., major depressive disorder, severe anxiety disorders, autism spectrum disorder)
- Neurological or sensory impairments affecting test performance
- Use of cognitive-enhancing supplements (e.g., omega-3, phosphatidylserine, citicoline) within the previous 8 weeks
- Severe ADHD requiring immediate pharmacological treatment
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 |
|---|---|---|
| PlaceboPlacebo formulation identical in appearance and administration to active supplements. | Other | Placebo Group |
| Phosphatidylserine-Omega3Also: Phosphatidylserine CapsuleCapsule containing 100 mg phosphatidylserine and 17.78 mg DHA administered once daily for 8 weeks. | Dietary supplement | PS Capsule Group |
| Phosphatidylserine-Omega3Also: Phosphatidylserine SachetSachet formulation containing 117.78 mg phosphatidylserine without DHA administered once daily for 8 weeks. | Dietary supplement | PS Sachet Group |
| DHA Omega-3Also: Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks.Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks. | Dietary supplement | PS Plus Group |
Primary outcome
Change in Attention and Executive Function Scores (MOXO and Stroop Tests)
Time frame: Baseline and 8 weeks
Change from baseline to 8 weeks in cognitive performance assessed using the MOXO continuous performance test (attention, impulsivity, timing, and hyperactivity domains) and the Stroop test (reaction time, error rates, and correction counts).
6 secondary outcomes
Change in MOXO Attention Score
Time frame: Baseline and 8 weeks
Change in MOXO Impulsivity Score
Time frame: Baseline and 8 weeks
Change in MOXO Hyperactivity Score
Time frame: Baseline and 8 weeks
Change in Stroop Reaction Time
Time frame: Baseline and 8 weeks
Change in Stroop Error Scores
Time frame: Baseline and 8 weeks
Change in Stroop Correction Counts
Time frame: Baseline and 8 weeks
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 13 Apr 2026.
- 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 Phosphatidylserine-Omega3 and DHA Omega-3 in people with Attention Deficit Hyperactivity Disorder (ADHD) and ADHD, run by Çağlar Charles Daniel Jaicks 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 5 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 13 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
Change in Attention and Executive Function Scores (MOXO and Stroop Tests) (time frame: Baseline and 8 weeks). 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 13 Apr 2026.