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NCT01248130 · ClinicalTrials.gov registry record · Phase 2
Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01248130: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01248130 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01248130, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study 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.
Primary Outcome
The SRS is a 65-item rating scale completed by the participants parent or guardian. The scale measures the severity of autism spectrum symptoms as the occur in natural social settings. The total raw score is calculated by summing the 65 items. Total scores range from 0 to 195, where higher scores indicate greater severity. The outcome reported reflects the change from baseline (pre-treatment) in SRS Total raw score. When examining change from baseline, negative scores represent improvement (i.e.
Interventions
- DRUG Omega-3 Fatty Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-11 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
Why NCT01248130 stopped before completion
NCT01248130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Omega-3 Fatty Acid is the first listed.
NCT01248130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01248130 about?
NCT01248130 is a clinical study titled "Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders". 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 yo...
What is the current status of trial NCT01248130?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2009-11. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01248130?
The interventions under investigation include: Omega-3 Fatty Acid (DRUG).
Who is sponsoring clinical trial NCT01248130?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01248130's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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