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COMPLETED NA

Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder

NCT00252486 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to test the hypothesis that flax oil, as an omega-3 fatty acid, will be superior to placebo in the maintenance treatment of bipolar disorder in children and adolescents. Our primary objective was to determine if flax oil is efficacious in the pediatric bipolar population for reducing symptoms of mania and depression. A secondary objective was to examine fatty acid levels as predictors of treatment response and symptom severity. This clinical trial evaluated whether supplementation with flax oil, containing the omega-3 fatty acid alpha-linolenic acid (alpha-LNA), safely reduced symptom severity in youth with bipolar disorder.

Conditions Studied

Interventions

  • DRUG Flax oil

Study Locations (1)

New York

  • University of Rochester — Rochester

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2001-11
Est. Completion 2005-06
Phase NA

Sponsor

University of Rochester

437 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00252486

The ClinicalTrials.gov registry entry for NCT00252486 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 437 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention — of which Flax oil is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00252486 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00252486 about?

NCT00252486 is a clinical study titled "Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder". The purpose of this study is to test the hypothesis that flax oil, as an omega-3 fatty acid, will be superior to placebo in the maintenance treatment of bipolar disorder in children and adolescents. Our primary objective was to determine if flax oil is efficacious in the pediatric bipolar populatio...

What is the current status of trial NCT00252486?

This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2001-11. Estimated completion is 2005-06.

What conditions does trial NCT00252486 study?

This clinical trial studies the following conditions: Bipolar Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00252486?

The interventions under investigation include: Flax oil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00252486?

This trial is sponsored by University of Rochester, which has 437 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00252486 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial