Trial Outcomes & Findings for The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder (NCT NCT00418184)

Results Overview

A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on classroom behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

200 participants

Primary outcome timeframe

change from baseline in conners raiting scale at 15 weeks

Results posted on

2014-03-12

Participant Flow

Children at the age of 6-13 years were screened at the "Geha mental health center", Israel, for participation in the study. Recruitment of participants was achieved by vast advertisement in newspapers, internet and in practitioners clinics. Participants enrollment period March 2007 to March 2008

Participant milestones

Participant milestones
Measure	PS Omega 3 Conjugate The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.	Placebo Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
Double-blind Phase STARTED	137	63
Double-blind Phase COMPLETED	110	52
Double-blind Phase NOT COMPLETED	27	11
Open-label Phase STARTED	102	48
Open-label Phase COMPLETED	97	43
Open-label Phase NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	PS Omega 3 Conjugate The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.	Placebo Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
Double-blind Phase Withdrawal by Subject	22	9
Double-blind Phase Adverse Event	2	1
Double-blind Phase Poor compliance	3	1

Baseline Characteristics

The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PS Omega 3 Conjugate n=137 Participants The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.	Placebo n=63 Participants Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3	Total n=200 Participants Total of all reporting groups
Age, Continuous	9.10 years STANDARD_DEVIATION 1.89 • n=99 Participants	9.24 years STANDARD_DEVIATION 1.77 • n=107 Participants	9.15 years STANDARD_DEVIATION 1.85 • n=206 Participants
Sex: Female, Male Female	45 Participants n=99 Participants	22 Participants n=107 Participants	67 Participants n=206 Participants
Sex: Female, Male Male	92 Participants n=99 Participants	41 Participants n=107 Participants	133 Participants n=206 Participants
Clinical Global Impression of Severity (CGI-S) Moderately ill (score 4)	83 Participants n=99 Participants	36 Participants n=107 Participants	119 Participants n=206 Participants
Clinical Global Impression of Severity (CGI-S) Seriously ill (score 5)	50 Participants n=99 Participants	27 Participants n=107 Participants	77 Participants n=206 Participants
Clinical Global Impression of Severity (CGI-S) Extremely seriously ill (score 6)	4 Participants n=99 Participants	0 Participants n=107 Participants	4 Participants n=206 Participants

PRIMARY outcome

Timeframe: change from baseline in conners raiting scale at 15 weeks

Population: The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.

A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on classroom behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.

Outcome measures

Outcome measures
Measure	PS Omega 3 Conjugate n=100 Participants The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.	Placebo n=47 Participants Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
Conners Rating Scale - School Version Conners Global Index: restless impulsivity	-0.44 Scores on a scale Standard Error 1.04	-1.73 Scores on a scale Standard Error 1.67
Conners Rating Scale - School Version Conners Global index: Emotional Lability	-2.63 Scores on a scale Standard Error 1.18	-0.63 Scores on a scale Standard Error 1.77
Conners Rating Scale - School Version Hyperactivity-impulsivity	-0.62 Scores on a scale Standard Error 1.09	-0.46 Scores on a scale Standard Error 1.25

SECONDARY outcome

Timeframe: change from baseline in conners raiting scale at 15 weeks

Population: The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.

A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on the childs home behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.

Outcome measures

Outcome measures
Measure	PS Omega 3 Conjugate n=100 Participants The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.	Placebo n=47 Participants Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
Conners Rating Scale - Home Version Conner's Global restless-impulsivity	-5.19 Scores on a scale Standard Error 1.00	-1.71 Scores on a scale Standard Error 1.72
Conners Rating Scale - Home Version Conner's Global Index:Emotional lability	-3.54 Scores on a scale Standard Error 1.08	-5.56 Scores on a scale Standard Error 1.80
Conners Rating Scale - Home Version DSM-IV: Hperactivity impulsivity	-4.23 Scores on a scale Standard Error 1.15	-2.62 Scores on a scale Standard Error 1.77

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PS Omega 3 Conjugate n=137 participants at risk The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.	Placebo n=63 participants at risk Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
Gastrointestinal disorders Abdominal pain	4.4% 6/137 • Number of events 7	1.6% 1/63 • Number of events 1

Additional Information

Yael Richter Ph.D

Enzymotec Ltd

Phone: +972 74 7177 177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER