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Due to a change in the research priorities of the principal investigator in combination with low subject interest.
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The primary aim of this study is to examine the efficacy and tolerability of short-term omega-3 fatty acids monotherapy in youth with Autism Spectrum Disorders (ASD). The investigators hypothesize that Omega-3 fatty acids will be efficacious in improving the core and associated features of ASD in youth, and that Omega-3 fatty acids monotherapy will be safe and well tolerated by youth with ASD. The secondary aim of this study is to examine the neuropsychological effect of Omega-3 fatty acids monotherapy in youth with ASD. The investigators hypothesize that omega-3 fatty acids will be efficacious in improving cognitive functions in youth with ASD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 Fatty Acid Treatment | Active Comparator |
| |
| Placebo (Sugar Pill) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Social Responsiveness Scale (SRS) Total Raw Score | 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). | Pre-treatment - 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores | The 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. |
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Inclusion
Exclusion
I.Q. < 85.
DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder.
Current diagnosis of a psychotic disorder or unstable mood or anxiety disorders as determined by the clinician.
Subject with marked severity of symptoms as suggested by the score of ≥ 5 (markedly ill) on CGI severity subscale for respective comorbid psychiatric disorders.
Clinically unstable psychiatric condition judged to be at a serious risk to self or others as determined by the clinician.
History of substance use (except nicotine or caffeine) within past 3 months, determined to be clinically significant by clinician.
Urine drug screen positive for substances of abuse.
Non-febrile seizures without a clear and resolved etiology in last month.
Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
Serious, unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease, as determined by clinician.
Any other concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication section of the protocol.
Subjects who have difficulty swallowing pills.
History of known allergy to Omega-3 fatty acids, multiple drug allergies, or severe allergies.
A non-responder of, or history of intolerance to Omega-3 fatty acids, after treatment at an adequate dose and duration as determined by the clinician.
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| Name | Affiliation | Role |
|---|---|---|
| Gagan Joshi, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Social Responsiveness Scale (SRS) Total Raw Score | 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). | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment - 12 weeks |
|
2 years
Spontaneously reported AEs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tiredness | General disorders |
|
This study was terminated early due to a change in the research priorities of the Principal Investigator in combination with low subject interest. Therefore, no data was analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gagan Joshi, MD | Massachusetts General Hospital | 617-726-4651 | lkfeinberg@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
|
| Pre-treatment - 12 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores | The 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment - 12 weeks |
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | 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. | 0 | 4 | 3 | 4 |
| Allergic reaction in eye | Immune system disorders |
|
| Decreased energy | General disorders |
|
| Anxiety | Psychiatric disorders |
|
| More isolative | Psychiatric disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Cold | Immune system disorders |
|
| Broke left wrist | Injury, poisoning and procedural complications |
|
| Headache | General disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Right leg pain | Musculoskeletal and connective tissue disorders |
|
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |