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NCT01260961 · ClinicalTrials.gov registry record · NA
Developing Treatment, Treatment Validation and Treatment Scope in the Setting of an Autism Clinical Trial
A NA study of Autism, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- NA
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT01260961: Active NA study of Autism, sponsored by Rutgers, The State University of New Jersey.
NCT01260961 is a NA study of Autism that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 132 participants, below the 182-participant average among 104 other Autism trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01260961, a NA study of Autism, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Docosahexanoic Acid
Study Locations (1)
New Jersey
- Rutgers - Piscataway
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2010-11 |
| Est. Completion | 2025-12-01 |
| Phase | NA |
What the registry record for NCT01260961 still lists
NCT01260961 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 182-participant average among 104 other Autism trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Autism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01260961 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT01260961 about?
NCT01260961 is a clinical study titled "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 ca...
What is the current status of trial NCT01260961?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 132 participants. The study started on 2010-11. Estimated completion is 2025-12-01.
What conditions does trial NCT01260961 study?
This clinical trial studies the following conditions: Autism.
What interventions are being tested in trial NCT01260961?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Docosahexanoic Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01260961?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01260961 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01260961's enrollment target sits among peer trials
132 32nd of 104 higher than 73 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism 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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