Status:
TERMINATED
Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Autism Spectrum Disorder (ASD)
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
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 tha...
Eligibility Criteria
Inclusion
- Inclusion
- Male or female participants between 6 and 17 years of age, inclusive.
- 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.
- Participants with at least moderate symptom severity of ASD as reflected by SRS score ≥ 85 and CGI-PDD severity score of ≥ 4 (moderately ill).
- Subjects must be psychotropic drug-free for a minimum of four weeks prior to the baseline visit.
- 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
- I.Q. \< 85.
- DSM-IV-TR PDD diagnoses of Rett's disorder, and childhood disintegrative disorder.
- Current diagnosis of a psychotic disorder or unstable mood or anxiety disorders as determined by the clinician.
- Subject with marked severity of symptoms as suggested by the score of ≥ 5 (markedly ill) on CGI severity subscale for respective comorbid psychiatric disorders.
- Clinically unstable psychiatric condition judged to be at a serious risk to self or others as determined by the clinician.
- History of substance use (except nicotine or caffeine) within past 3 months, determined to be clinically significant by clinician.
- Urine drug screen positive for substances of abuse.
- Non-febrile seizures without a clear and resolved etiology in last month.
- Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
- Pregnant or nursing females;
- Organic brain disorders;
- Uncorrected hypothyroidism or hyperthyroidism, as determined by study clinician;
- Untreated and/or unstable diabetes;
- Subjects with a clinically significant abnormality according to cardiology consultation (ECGs with clinically concerning intervals including PR, QTC, QRS, will be reviewed by cardiology).
- History of renal or hepatic impairment determined to be clinically significant by clinician.
- Serious, unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease, as determined by clinician.
- Any other concomitant medication with primary central nervous system activity other than specified in the Concomitant Medication section of the protocol.
- Subjects who have difficulty swallowing pills.
- History of known allergy to Omega-3 fatty acids, multiple drug allergies, or severe allergies.
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01248130
Start Date
November 1 2009
End Date
April 1 2013
Last Update
March 27 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114