Developing Treatment, Treatment Validation and Treatment Scope in the Setting of an Autism Clinical Trial

NCT01260961 | Active Not Recruiting DMC

• 1 other identifier: 0220080189
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

• 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

  three years

Secondary Outcomes (1)

• oxidative stress biomarkers

  Three years

Study Arms (2)

Docosa Hexanoic Acid

ACTIVE COMPARATOR

Dietary Supplement: Docosahexanoic Acid

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

The volunteers will start on the 200 mg daily of the placebo and will not increase their dose during the study.

Placebo

Docosahexanoic Acid DIETARY_SUPPLEMENT

The volunteers will start on the 200 mg daily of the DHA capsule and will not increase their dose during the study.

Also known as: DHA

Docosa Hexanoic Acid

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Subjects who are pregnant or nursing mothers.
• 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.
• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sherie Novotny, MD

  Rutgers-RWJMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: December 15, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)