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Completed

NCT Number: NCT07521449

Effects of Phosphatidylserine and DHA on Cognitive Performance in Children With ADHD

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydin University, Department of Child and Adolescent Psychiatry, Istanbul, Turkey

Istanbul, 34295, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Placebo

Other

Placebo formulation identical in appearance and administration to active supplements.

Phosphatidylserine-Omega3

Dietary Supplement

Capsule containing 100 mg phosphatidylserine and 17.78 mg DHA administered once daily for 8 weeks.

Other names: Phosphatidylserine Capsule

DHA Omega-3

Dietary Supplement

Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks.

Other names: Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in MOXO Attention Score

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks in attention performance measured by MOXO d-CPT.

  2. Change in MOXO Impulsivity Score

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks in impulsivity measured by MOXO d-CPT.

  3. Change in MOXO Hyperactivity Score

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks in hyperactivity measured by MOXO d-CPT.

  4. Change in Stroop Reaction Time

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks in reaction time measured by the Stroop test.

  5. Change in Stroop Error Scores

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks in error rates measured by the Stroop test.

  6. Change in Stroop Correction Counts

    Time frame: Baseline and 8 weeks

    Change from baseline to 8 weeks in correction counts measured by the Stroop test.

Sponsors and collaborators

Lead sponsor

Çağlar Charles Daniel Jaicks

Other

Registry information

Official study title

Differential Cognitive Effects of DHA-Enriched and Standard Phosphatidylserine Formulations in Children With ADHD: A Randomized Placebo-Controlled Trial

Acronym: PS-DHA-ADHD

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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