Effects of Phosphatidylserine and DHA on Cognitive Performance in Children With ADHD (PS-DHA-ADHD)
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34295
- Istanbul Aydin University, Department of Child and Adolescent Psychiatry, Istanbul, Turkey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo Group
Participants received placebo once daily for 8 weeks.
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Placebo formulation identical in appearance and administration to active supplements.
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Experimental: PS Capsule Group
Participants received phosphatidylserine capsule with DHA once daily for 8 weeks.
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Capsule containing 100 mg phosphatidylserine and 17.78 mg DHA administered once daily for 8 weeks.
Other Names:
Sachet formulation containing 117.78 mg phosphatidylserine without DHA administered once daily for 8 weeks.
Other Names:
|
|
Experimental: PS Sachet Group
Participants received phosphatidylserine sachet without DHA once daily for 8 weeks.
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Capsule containing 100 mg phosphatidylserine and 17.78 mg DHA administered once daily for 8 weeks.
Other Names:
Sachet formulation containing 117.78 mg phosphatidylserine without DHA administered once daily for 8 weeks.
Other Names:
|
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Experimental: PS Plus Group
Participants received higher-dose phosphatidylserine with DHA once daily for 8 weeks.
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Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Attention and Executive Function Scores (MOXO and Stroop Tests)
Time Frame: Baseline and 8 weeks
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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).
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Baseline and 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in MOXO Attention Score
Time Frame: Baseline and 8 weeks
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Change from baseline to 8 weeks in attention performance measured by MOXO d-CPT.
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Baseline and 8 weeks
|
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Change in MOXO Impulsivity Score
Time Frame: Baseline and 8 weeks
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Change from baseline to 8 weeks in impulsivity measured by MOXO d-CPT.
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Baseline and 8 weeks
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Change in MOXO Hyperactivity Score
Time Frame: Baseline and 8 weeks
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Change from baseline to 8 weeks in hyperactivity measured by MOXO d-CPT.
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Baseline and 8 weeks
|
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Change in Stroop Reaction Time
Time Frame: Baseline and 8 weeks
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Change from baseline to 8 weeks in reaction time measured by the Stroop test.
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Baseline and 8 weeks
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Change in Stroop Error Scores
Time Frame: Baseline and 8 weeks
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Change from baseline to 8 weeks in error rates measured by the Stroop test.
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Baseline and 8 weeks
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Change in Stroop Correction Counts
Time Frame: Baseline and 8 weeks
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Change from baseline to 8 weeks in correction counts measured by the Stroop test.
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Baseline and 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PS-DHA-ADHD-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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