Effects of Phosphatidylserine and DHA on Cognitive Performance in Children With ADHD (PS-DHA-ADHD)

Çağlar Charles Daniel Jaicks

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder (ADHD); ADHD

Treatments: Other: Placebo; Dietary Supplement: Phosphatidylserine-Omega3; Dietary Supplement: DHA Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT07521449

PS-DHA-ADHD-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 10 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 4 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Participants received placebo once daily for 8 weeks.

Treatment:

Other: Placebo

PS Capsule Group

Experimental group

Description:

Participants received phosphatidylserine capsule with DHA once daily for 8 weeks.

Treatment:

Dietary Supplement: Phosphatidylserine-Omega3

Dietary Supplement: Phosphatidylserine-Omega3

PS Sachet Group

Experimental group

Description:

Participants received phosphatidylserine sachet without DHA once daily for 8 weeks.

Treatment:

Dietary Supplement: Phosphatidylserine-Omega3

Dietary Supplement: Phosphatidylserine-Omega3

PS Plus Group

Experimental group

Description:

Participants received higher-dose phosphatidylserine with DHA once daily for 8 weeks.

Treatment:

Dietary Supplement: DHA Omega-3