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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT01260961
First received: November 23, 2010
Last updated: August 29, 2013
Last verified: August 2013

November 23, 2010
August 29, 2013
November 2010
December 2015   (final data collection date for primary outcome measure)
Amelioration of phenotypic features of autism [ Time Frame: three years ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01260961 on ClinicalTrials.gov Archive Site
oxidative stress biomarkers [ Time Frame: Three years ] [ Designated as safety issue: No ]

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.

Same as current
Not Provided
Not Provided
 
Developing Treatment, Treatment Validation and Treatment Scope in the Setting of an Autism Clinical Trial
Developing Treatment, Treatment Validation and Treatment Scope in the Setting of an Autism Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism
  • Dietary Supplement: Placebo
    The volunteers will start on the 200 mg daily of the placebo and will not increase their dose during the study.
    Other Name: Placebo
  • Dietary Supplement: Docosahexanoic Acid
    The volunteers will start on the 200 mg daily of the DHA capsule and will not increase their dose during the study.
    Other Name: DHA
  • Active Comparator: Docosa Hexanoic Acid
    Intervention: Dietary Supplement: Docosahexanoic Acid
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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)
Both
5 Years to 17 Years
No
Contact: Sherie Novotny, MD 732-235 ext 4119 novotnsl@umdnj.edu
United States
 
NCT01260961
0220080189
Yes
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
Not Provided
Principal Investigator: Sherie Novotny, MD UMDNJ-RWJMS
Rutgers, The State University of New Jersey
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP