Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Aberrant Behavior Checklist (ABC)
Study Overview
Brief Summary
Published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in Clinical Global Impression Scale, Young Mania Rating Scale, and HAM-D scores. The following are the hypotheses:
- Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism.
- Omega 3 fatty acids will be superior to placebo in improving aggression and irritability associated with autism.
- Omega 3 fatty acids will be superior to placebo in improving functional ability.
Detailed Description
This study is an innovative treatment approach to autism. It adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. It will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. Finally, it will attempt to identify which specific subgroups of subjects will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects' quality of life. The data generated by this study is intended to support the rationale for a full scale, large multi-site clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Child/Teen has autism.
- •He/She is between five and seventeen years of age.
- •He/She is not in the hospital.
- •He/She has a parent or legal guardian who is willing and able to sign the informed consent.
Exclusion Criteria
- •Child/Teen has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
- •He/She has caused visible harm to him/herself or is at risk for suicide.
- •He/She has an active seizure disorder or epilepsy (seizures within the past year).
- •He/She has an unstable medical illness, including heart disease.
- •He/She has experienced brain injury.
- •He/She has a history of diabetes.
- •He/She has a history of prior treatment with Omega 3 Fatty Acids.
- •He/She lives in a far away area and/or does not have regular access to transportation to the clinical facility.
- •A pregnant female or unwilling to use acceptable contraception if sexually active.
Arms & Interventions
Omega 3 fatty Acids, drug
Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.
Intervention: Omega 3 fatty acids (Drug)
Placebo
The placebo will be dispensed to subjects in the control group
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Aberrant Behavior Checklist (ABC)
Time Frame: Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported
Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart \& Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes.
Clinical Global Impression Scale(CGI)- Improvement
Time Frame: Administered biweekly, endpoint score (week 12) only used for data analysis
This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale.
Vineland Adaptive Behavior Scale
Time Frame: Administered during the baseline visit and on week 12 ( termination)
The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity.
Secondary Outcomes
- Parental Stress Index(Administered during the baseline visit and on week 12 ( termination))
- Overt Aggression Scale-Modified(Administered biweekly and at week 12 (termination))
Investigators
Sherie Novotny, M.D.
Assistant Professor, Psychiatry, RWJMS
Rutgers, The State University of New Jersey