Trial Outcomes & Findings for Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders (NCT NCT01248130)
NCT ID: NCT01248130
Last Updated: 2025-03-27
Results Overview
The SRS is a 65-item rating scale completed by the participants parent or guardian. The scale measures the severity of autism spectrum symptoms as the occur in natural social settings. The total raw score is calculated by summing the 65 items. Total scores range from 0 to 195, where higher scores indicate greater severity. The outcome reported reflects the change from baseline (pre-treatment) in SRS Total raw score. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Pre-treatment - 12 weeks
Results posted on
2025-03-27
Participant Flow
Participant milestones
| Measure |
Omega-3 Fatty Acid Treatment
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
Placebo (Sugar Pill)
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Omega-3 Fatty Acid Treatment
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
Placebo (Sugar Pill)
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Ineligible
|
1
|
0
|
Baseline Characteristics
Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Omega-3 Fatty Acid Treatment
n=3 Participants
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
Placebo (Sugar Pill)
n=4 Participants
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
4 participants
n=41 Participants
|
7 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment - 12 weeksThe SRS is a 65-item rating scale completed by the participants parent or guardian. The scale measures the severity of autism spectrum symptoms as the occur in natural social settings. The total raw score is calculated by summing the 65 items. Total scores range from 0 to 195, where higher scores indicate greater severity. The outcome reported reflects the change from baseline (pre-treatment) in SRS Total raw score. When examining change from baseline, negative scores represent improvement (i.e., decrease in severity from baseline).
Outcome measures
| Measure |
Omega-3 Fatty Acid Treatment
n=1 Participants
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
Placebo (Sugar Pill)
n=4 Participants
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
|---|---|---|
|
Change From Baseline in Social Responsiveness Scale (SRS) Total Raw Score
|
0 score on a scale
Standard Deviation NA
Only 1 participant in this Arm.
|
-7 score on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: Pre-treatment - 12 weeksThe CGI-PDD Improvement scale is a clinician-rated assessment of the participant's improvement in symptoms compared to baseline. The CGI-PDD-I is rated on a scale of one (very much improved) to seven (very much worse) and values of zero (not assessed) are assigned to all participants at baseline. The outcome reported reflects the change in improvement score from baseline, where lower scores indicate greater improvement compared to baseline.
Outcome measures
| Measure |
Omega-3 Fatty Acid Treatment
n=1 Participants
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
Placebo (Sugar Pill)
n=4 Participants
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
|---|---|---|
|
Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores
|
4 score on a scale
Standard Deviation NA
Only 1 participant in this Arm.
|
3.3 score on a scale
Standard Deviation 1.0
|
Adverse Events
Omega-3 Fatty Acid Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Sugar Pill)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3 Fatty Acid Treatment
n=3 participants at risk
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
Placebo (Sugar Pill)
n=4 participants at risk
Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
|
|---|---|---|
|
General disorders
Tiredness
|
33.3%
1/3 • Number of events 1 • 2 years
Spontaneously reported AEs
|
0.00%
0/4 • 2 years
Spontaneously reported AEs
|
|
Immune system disorders
Allergic reaction in eye
|
33.3%
1/3 • Number of events 1 • 2 years
Spontaneously reported AEs
|
0.00%
0/4 • 2 years
Spontaneously reported AEs
|
|
General disorders
Decreased energy
|
33.3%
1/3 • Number of events 1 • 2 years
Spontaneously reported AEs
|
0.00%
0/4 • 2 years
Spontaneously reported AEs
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • 2 years
Spontaneously reported AEs
|
0.00%
0/4 • 2 years
Spontaneously reported AEs
|
|
Psychiatric disorders
More isolative
|
33.3%
1/3 • Number of events 1 • 2 years
Spontaneously reported AEs
|
0.00%
0/4 • 2 years
Spontaneously reported AEs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 2 years
Spontaneously reported AEs
|
25.0%
1/4 • Number of events 1 • 2 years
Spontaneously reported AEs
|
|
Immune system disorders
Cold
|
0.00%
0/3 • 2 years
Spontaneously reported AEs
|
25.0%
1/4 • Number of events 2 • 2 years
Spontaneously reported AEs
|
|
Injury, poisoning and procedural complications
Broke left wrist
|
0.00%
0/3 • 2 years
Spontaneously reported AEs
|
25.0%
1/4 • Number of events 1 • 2 years
Spontaneously reported AEs
|
|
General disorders
Headache
|
0.00%
0/3 • 2 years
Spontaneously reported AEs
|
25.0%
1/4 • Number of events 1 • 2 years
Spontaneously reported AEs
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • 2 years
Spontaneously reported AEs
|
0.00%
0/4 • 2 years
Spontaneously reported AEs
|
|
Musculoskeletal and connective tissue disorders
Right leg pain
|
33.3%
1/3 • Number of events 1 • 2 years
Spontaneously reported AEs
|
0.00%
0/4 • 2 years
Spontaneously reported AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place