Trial Outcomes & Findings for Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders (NCT NCT00467818)

Results Overview

This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Administered biweekly, endpoint score (week 12) only used for data analysis

Results posted on

2021-01-26

Participant Flow

Recruitment was difficult for this study due to multiple disruptions in the flow of the study due to issues with the IRB process. Additionally, there were periods of time when there was not a research coordinator to assist with recruitment and pt flow.

Participants were required to undergo diagnostic testing and intelligence testing prior to starting the study. Individuals who were unable to participate in these processes were not allowed to enter into the active phase of the study.

Participant milestones

Participant milestones
Measure	Omega 3 Fatty Acids, Drug Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Placebo The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids
Overall Study STARTED	9	8
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Omega 3 Fatty Acids, Drug Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Placebo The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omega 3 Fatty Acids, Drug n=9 Participants Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Placebo n=8 Participants The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	11.7 years STANDARD_DEVIATION 3.5 • n=5 Participants	10.6 years STANDARD_DEVIATION 3.5 • n=7 Participants	11.2 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Administered biweekly, endpoint score (week 12) only used for data analysis

This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale.

Outcome measures

Outcome measures
Measure	Omega 3 Fatty Acids, Drug n=6 Participants Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Placebo n=6 Participants The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids
Clinical Global Impression Scale(CGI)- Improvement	3.57 units on a scale Standard Deviation 1.2	3.8 units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported

Population: Youth and adolescents ages 5-17 with autism spectrum disorder

Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart \& Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes.

Outcome measures

Outcome measures
Measure	Omega 3 Fatty Acids, Drug n=6 Participants Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Placebo n=6 Participants The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids
Aberrant Behavior Checklist (ABC)	5.66 units on a scale Standard Deviation 5.0	8.5 units on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: Administered during the baseline visit and on week 12 ( termination)

The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity.

Outcome measures

Outcome measures
Measure	Omega 3 Fatty Acids, Drug n=6 Participants Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Placebo n=6 Participants The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids
Vineland Adaptive Behavior Scale	51.5 units on a scale Standard Deviation 13.28	27.5 units on a scale Standard Deviation 9.81

SECONDARY outcome

Timeframe: Administered biweekly and at week 12 (termination)

The Modified version, Coccaro et al. is designed for outpatient use and assessment of behavior over one week. This scale was assessed biweekly. The OAS-M consists of 3 domains: Aggression, Irritability, and Suicidality (not used). Aggression Domain: 4 subscales of weighted behavior: Verbal Aggression (1), Aggression Against Objects (2), Aggression Against Others (3), and Self-Aggression (4). Within each category, severity of an event receives a scaled score (0-5) (higher score for worse behaviors) which is then multiplied by the weekly frequency of this event and weight, then totaled (for use in this study). Irritability subscale is divided into subjective/objective, 0 (low)-5 (high). The total scale has a minimum value of 0 (no display of aggressive/irritable behavior) and a maximum value of infinity (worse aggressive/irritable behavior) as reporting the number of times an aggressive/irritable behavior occurred does not have a maximum value). Higher scores mean worse outcome.

Outcome measures

Outcome measures
Measure	Omega 3 Fatty Acids, Drug n=6 Participants Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Placebo n=6 Participants The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids
Overt Aggression Scale-Modified	3.8 units on a scale Standard Deviation 2.7	2.4 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Administered during the baseline visit and on week 12 ( termination)

This measurement assesses child and parental characteristics and parent-child relationship dimensions associated with the presence of parenting stress/ troubled relationships. It is a self-report scale completed by the parent, consisting of 101 items organized into two domains with the following subscales: (1) child characteristics domain - adaptability, demandingness, mood, distractibility/hyperactivity, acceptability of child to parent, and child's reinforcement of parent, and (2) parent characteristics domain - depression, attachment to child, social isolation, sense of competence in the parenting role, relationship with spouse/parenting partner, role restrictions, and parental health. Scores are 1-5 with 1 being strongly agree and 5 being strongly disagree. Scores are collected and standardized. The higher a score is, the more stress a parent is experiencing. Minimum value is 101 and maximum value is 505.

Outcome measures

Outcome measures
Measure	Omega 3 Fatty Acids, Drug n=6 Participants Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Placebo n=6 Participants The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids
Parental Stress Index	314.2 units on a scale Standard Deviation 35.2	279.5 units on a scale Standard Deviation 35.4

Adverse Events

Omega 3 Fatty Acids, Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omega 3 Fatty Acids, Drug n=9 participants at risk Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.	Placebo n=8 participants at risk The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids
Psychiatric disorders Recurrence of mood disorder in one participant	0.00% 0/9 • The adverse event data were collected over the course of the study from the start in 2007 until completion in 2011. Each participant was observed for adverse events during the course of their treatment which was the course of the study, ie 12 weeks. Participants were not monitored for adverse events after the completion of the study.	12.5% 1/8 • Number of events 1 • The adverse event data were collected over the course of the study from the start in 2007 until completion in 2011. Each participant was observed for adverse events during the course of their treatment which was the course of the study, ie 12 weeks. Participants were not monitored for adverse events after the completion of the study.

Other adverse events

Adverse event data not reported

Additional Information

Sherie Novotny MD

UMDNJ

Phone: (732) 235-4119

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place