ADHD, Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Keywords
Phosphatidylserine, DHA, Cognitive Function, Executive Function, MOXO Test, Stroop Test
Brief 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. 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.
Interventions
OTHERPlacebo
Placebo formulation identical in appearance and administration to active supplements.
DIETARY_SUPPLEMENTPhosphatidylserine-Omega3
Capsule containing 100 mg phosphatidylserine and 17.78 mg DHA administered once daily for 8 weeks.
DIETARY_SUPPLEMENTDHA Omega-3
Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks.
Sponsors
Çağlar Charles Daniel Jaicks
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, investigators, and outcome assessors were blinded to group assignments. Placebo and active formulations were identical in appearance and administration.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Attention and Executive Function Scores (MOXO and Stroop Tests) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in MOXO Attention Score | Baseline and 8 weeks | Change from baseline to 8 weeks in attention performance measured by MOXO d-CPT. |
| Change in MOXO Impulsivity Score | Baseline and 8 weeks | Change from baseline to 8 weeks in impulsivity measured by MOXO d-CPT. |
| Change in MOXO Hyperactivity Score | Baseline and 8 weeks | Change from baseline to 8 weeks in hyperactivity measured by MOXO d-CPT. |
| Change in Stroop Reaction Time | Baseline and 8 weeks | Change from baseline to 8 weeks in reaction time measured by the Stroop test. |
| Change in Stroop Error Scores | Baseline and 8 weeks | Change from baseline to 8 weeks in error rates measured by the Stroop test. |
| Change in Stroop Correction Counts | Baseline and 8 weeks | Change from baseline to 8 weeks in correction counts measured by the Stroop test. |
Countries
Turkey (Türkiye)
Outcome results
None listed