Clinical trial NCT01248130: Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
Official title: Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Autism Spectrum Disorder (ASD)
Keywords: Omega-3 Fatty Acid
Autism Spectrum Disorders
Pervasive Developmental Disorders
Children
Cognitive Functioning
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 7
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion

1. Male or female participants between 6 and 17 years of age, inclusive.
2. Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical interview assisted by MGH PDD Symptom Checklist.
3. Participants with at least moderate symptom severity of ASD as reflected by SRS score ≥ 85 and CGI-PDD severity score of ≥ 4 (moderately ill).
4. Subjects must be psychotropic drug-free for a minimum of four weeks prior to the baseline visit.
5. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion

1. I.Q. \< 85.
2. DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder.
3. Current diagnosis of a psychotic disorder or unstable mood or anxiety disorders as determined by the clinician.
4. Subject with marked severity of symptoms as suggested by the score of ≥ 5 (markedly ill) on CGI severity subscale for respective comorbid psychiatric disorders.
5. Clinically unstable psychiatric condition judged to be at a serious risk to self or others as determined by the clinician.
6. History of substance use (except nicotine or caffeine) within past 3 months, determined to be clinically significant by clinician.
7. Urine drug screen positive for substances of abuse.
8. Non-febrile seizures without a clear and resolved etiology in last month.
9. Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:

   1. Pregnant or nursing females;
   2. Organic brain disorders;
   3. Uncorrected hypothyroidism or hyperthyroidism, as determined by study clinician;
   4. Untreated and/or unstable diabetes;
   5. Subjects with a clinically significant abnormality according to cardiology consultation (ECGs with clinically concerning intervals including PR, QTC, QRS, will be reviewed by cardiology).
   6. History of renal or hepatic impairment determined to be clinically significant by clinician.
10. Serious, unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease, as determined by clinician.
11. Any other concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication section of the protocol.
12. Subjects who have difficulty swallowing pills.
13. History of known allergy to Omega-3 fatty acids, multiple drug allergies, or severe allergies.
14. 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.

Primary outcomes:
measure: Change From Baseline in Social Responsiveness Scale (SRS) Total Raw Score
timeFrame: Pre-treatment - 12 weeks
Secondary outcomes:
measure: Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores
timeFrame: Pre-treatment - 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gagan Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: