AutismNCT01260961
Developing Treatment, Treatment Validation and Treatment Scope in the Setting of an Autism Clinical Trial
A study testing Docosahexanoic Acid in people with Autism, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3 fatty acid found in the brain and a component of fish oil, has any effects on the symptoms of autism. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autism
- What is being tested?
- Docosahexanoic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV, ADI, and ADOS criteria for autistic disorder
- Age 5-17.
- Outpatients
- Parent or legal guardian signing informed consent, and assent documented for patient with demonstrated capacity to provide it.
- Sexually active females of childbearing potential must use an acceptable method of birth control (oral contraceptive medications [the administration of which must be supervised by a parent or guardian], IUD, depot medication, double barrier or tubal ligation) and have a negative serum pregnancy test prior to entry into the study.
- Subjects with history of seizures, who have been seizure-free for more than or equal to 6 months on a stable dose of anticonvulsant medication.Non-medicated subjects with a history of seizures who have been seizure-free for more than or equal to 6 months.Subjects with abnormal EEG but no clinical seizures.
Who cannot join
- Subjects who are pregnant or nursing mothers.
- Sexually active females of childbearing potential who are not using adequate birth control measures (detailed above in inclusion criteria).
- Subjects with overall adaptive behavior scores below the age of two years on the Vineland Adaptive Behavior Rating Scale.
- Subjects with active or unstable epilepsy.
- Subjects with any of the following past or present mental disorders: schizophrenia, schizoaffective disorder, major depressive disorder, bipolar I or II disorders or substance abuse disorders.
- Subjects who are a serious suicidal risk.
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- Subjects with clinically significant or unstable medical illness that would contraindicate participation in the study, including hematopoietic or cardiovascular disease, pancreatitis, liver toxicity, and polycystic ovary syndrome
- Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, pica, neurofibromatosis, hypomelanosis of Ito, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella.
- Patients with history of the following:gastrointestinal, liver, or kidney, or other known conditions which will presently interfere presently with the absorption, distribution, metabolism, or excretion of drugs, cerebrovascular disease or brain trauma, clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism, recent history or presence of any form of malignancy
- Treatment within the previous 30 days with any drug known to a well-defined potential for toxicity to a major organ
- Subjects with clinically significant abnormalities in laboratory tests or physical exam
- Subjects likely to require ECT.
- Subjects unable to tolerate taper from psychoactive medication if necessary.
- Subjects with a history of hypersensitivity or severe side effects associated with the use of divalproex sodium, or other an ineffective prior therapeutic trial of omega three fatty acids.
- Subjects who have received any of the following interventions within the prescribed period before starting treatment-investigational drugs within the previous 30 days.
- Subjects who have begun any new alternative non-medication treatments, such as diet, vitamins, and psychosocial therapy, within the previous three months.
- Subjects with any organic or systemic disease or patients who require a therapeutic intervention, not otherwise specified, which would confound the evaluation of the safety of the study medication.
- Subjects who reside in a remote geographical area who do not have regular access to transportation to the clinical facility.
- If a patient is not doing well enough (defined by CGI-AD Severity score of 3-"mildly ill" or better)
Trial locations and contacts
1 site in 1 country.
About this study
Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3 fatty acid found in the brain and a component of fish oil, has any effects on the symptoms of autism.
We propose to carry out a trial to test the effect of DHA compared to a placebo (a pill with no drug in it) on several aspects of autism in children and adolescents, in a 12-week clinical study with children or adolescents in the age group of 5-17 with a diagnosis of Autism Spectrum Disorder. Additionally this trial will study genes related to the therapeutic agent, DHA, and biomarkers related to DHA in the urine.
Read the detailed description
Growing evidence supports oxidative stress may contribute to autism. Docosa Hexanoic Acid(DHA)is a normal substance that is present in large amounts in the brain and can be used by the body to produce natural antioxidants. Our hope is that supplementing DHA in individuals with autism may improve some aspects of their functioning. Specifically our aims are:
Aim 1. To assess the effect of DHA vs. placebo treatment on the global severity of child and adolescent autistic disorder, via a 12-week double blind placebo-controlled parallel study. Global severity will be assessed by the Autism Diagnostic Observation Schedule-Generic (ADOS-G) and additionally in younger children by the Vineland Adaptive Behavior Scale.
Aim 2. To assess the effect of DHA vs. placebo treatment on behavioral symptoms and functional ability in children with autism. Assessment will be by the Aberrant Behavior Checklist (ABC)-Community Version11.
Aim 3. To develop an improved protocol and study design based upon these studies for future large scale studies of DHA in the autistic population.
Aim 4. Monitor the effects of therapy on the isoprostane biomarker. Aim 5: Develop additional biomarkers that correlate with autism and with therapy. We will extend the analyses to neuroprostanes and resolvins. We will measure: (i) Urinary excretion of the isoprostane metabolites, 2,3 Dinor-5,6 dihydro-PGF2t and iPF4α-VI. (ii) DHA derived resolvins D2, D4, D5 and D6 and neuroprotectin.
Aim 6: Confirm our preliminary results by correlating increased isoprostane excretion with GSTM1*0 copy number in individuals with autism.
Aim 7: In the same way, correlate GSTM1*0 copy number with response to therapy assessed by diminution of isoprostane excretion during therapy.
Aim 8: Study additional biomarkers developed through Hypothesis #2 for correlation with GSTM1*0 copy number and response to therapy to identify additional gene-biomarker correlations.
Aim 9: Study additional polymorphisms of genes related to DHA metabolism, for association with autism, gene-biomarker correlations, and correlation with response to therapy.
- Conditions
- Autism
- Being tested
- Placebo, Docosahexanoic Acid
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
The volunteers will start on the 200 mg daily of the placebo and will not increase their dose during the study.
Docosahexanoic AcidDietary supplement
Also called DHA
The volunteers will start on the 200 mg daily of the DHA capsule and will not increase their dose during the study.
| Study group | Role | What they receive |
|---|---|---|
| Docosa Hexanoic Acid | Active comparator | Not described Receives: Dietary Supplement: Docosahexanoic Acid |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amelioration of phenotypic features of autism
Amelioration of phenotypic features of autism as measured by a significant decrease from the baseline, in global severity of autism score and Aberrant Behavior Checklist scores
Measured: three years
Secondary outcomes (1)
oxidative stress biomarkers
We will be measuring isoprostane 8-iso-PGF2a.
The measurements will be in ng mg Creatinine and we expect a significant decrease in levels from the baseline.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2015
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherie Novotny, M.D., Rutgers, The State University of New Jersey
- Investigators
- Sherie Novotny, MD, Principal investigator, Rutgers-RWJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260961
- Sponsor's protocol ID
- 0220080189
- Status last verified
- Jun 2026
- First submitted
- 23 Nov 2010
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Treatment, Treatment Validation and Treatment Scope in the Setting of an Autism Clinical Trial
- ClinicalTrials.gov ID
- NCT01260961
- Acronym / sponsor ID
- 0220080189
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dr. Sherie Novotny of the Department of Psychiatry at UMDNJ-RWJMS and collaborators are starting a treatment trial to determine whether Docosa Hexanoic Acid(DHA), the major omega-3 fatty acid found in the brain and a component of fish oil, has any effects on the symptoms of autism.
We propose to carry out a trial to test the effect of DHA compared to a placebo (a pill with no drug in it) on several aspects of autism in children and adolescents, in a 12-week clinical study with children or adolescents in the age group of 5-17 with a diagnosis of Autism Spectrum Disorder. Additionally this trial will study genes related to the therapeutic agent, DHA, and biomarkers related to DHA in the urine.
Detailed description
Growing evidence supports oxidative stress may contribute to autism. Docosa Hexanoic Acid(DHA)is a normal substance that is present in large amounts in the brain and can be used by the body to produce natural antioxidants. Our hope is that supplementing DHA in individuals with autism may improve some aspects of their functioning. Specifically our aims are:
Aim 1. To assess the effect of DHA vs. placebo treatment on the global severity of child and adolescent autistic disorder, via a 12-week double blind placebo-controlled parallel study. Global severity will be assessed by the Autism Diagnostic Observation Schedule-Generic (ADOS-G) and additionally in younger children by the Vineland Adaptive Behavior Scale.
Aim 2. To assess the effect of DHA vs. placebo treatment on behavioral symptoms and functional ability in children with autism. Assessment will be by the Aberrant Behavior Checklist (ABC)-Community Version11.
Aim 3. To develop an improved protocol and study design based upon these studies for future large scale studies of DHA in the autistic population.
Aim 4. Monitor the effects of therapy on the isoprostane biomarker. Aim 5: Develop additional biomarkers that correlate with autism and with therapy. We will extend the analyses to neuroprostanes and resolvins. We will measure: (i) Urinary excretion of the isoprostane metabolites, 2,3 Dinor-5,6 dihydro-PGF2t and iPF4α-VI. (ii) DHA derived resolvins D2, D4, D5 and D6 and neuroprotectin.
Aim 6: Confirm our preliminary results by correlating increased isoprostane excretion with GSTM1*0 copy number in individuals with autism.
Aim 7: In the same way, correlate GSTM1*0 copy number with response to therapy assessed by diminution of isoprostane excretion during therapy.
Aim 8: Study additional biomarkers developed through Hypothesis #2 for correlation with GSTM1*0 copy number and response to therapy to identify additional gene-biomarker correlations.
Aim 9: Study additional polymorphisms of genes related to DHA metabolism, for association with autism, gene-biomarker correlations, and correlation with response to therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docosa Hexanoic Acid | Active comparator | Dietary Supplement: Docosahexanoic Acid |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Meets DSM-IV, ADI, and ADOS criteria for autistic disorder
- Age 5-17.
- Outpatients
- Parent or legal guardian signing informed consent, and assent documented for patient with demonstrated capacity to provide it.
- Sexually active females of childbearing potential must use an acceptable method of birth control (oral contraceptive medications [the administration of which must be supervised by a parent or guardian], IUD, depot medication, double barrier or tubal ligation) and have a negative serum pregnancy test prior to entry into the study.
Key exclusion criteria (19 listed)
- Subjects who are pregnant or nursing mothers.
- Sexually active females of childbearing potential who are not using adequate birth control measures (detailed above in inclusion criteria).
- Subjects with overall adaptive behavior scores below the age of two years on the Vineland Adaptive Behavior Rating Scale.
- Subjects with active or unstable epilepsy.
- Subjects with any of the following past or present mental disorders: schizophrenia, schizoaffective disorder, major depressive disorder, bipolar I or II disorders or substance abuse disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe volunteers will start on the 200 mg daily of the placebo and will not increase their dose during the study. | Dietary supplement | Placebo |
| Docosahexanoic AcidAlso: DHAThe volunteers will start on the 200 mg daily of the DHA capsule and will not increase their dose during the study. | Dietary supplement | Docosa Hexanoic Acid |
Primary outcome
Amelioration of phenotypic features of autism
Time frame: three years
Amelioration of phenotypic features of autism as measured by a significant decrease from the baseline, in global severity of autism score and Aberrant Behavior Checklist scores
1 secondary outcome
oxidative stress biomarkers
Time frame: Three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherie Novotny, MD principal investigator
Rutgers-RWJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docosahexanoic Acid in people with Autism, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amelioration of phenotypic features of autism (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.