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NCT01396486 · ClinicalTrials.gov registry record · Phase 4

Inositol and Omega-3 Fatty Acids in Pediatric Mania

A Phase 4 study of Pediatric Bipolar Spectrum Disorders, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 4
Development phase
69
Enrollment target
1
Study location

NCT01396486 is a Phase 4 study of Pediatric Bipolar Spectrum Disorders that has completed, run by Massachusetts General Hospital. The registered enrollment target is 69 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT01396486, a Phase 4 study of Pediatric Bipolar Spectrum Disorders, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 4
Development phase
69 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3 fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the side effect profile of omega-3 fatty acids plus inositol. This study will be a 12-week trial with children ages 5-12 years old with bipolar spectrum disorders.

Interventions

  • DRUG Omega-3
  • DRUG Inositol

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2012-02-03
Est. Completion 2019-04-11
Phase Phase 4

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT01396486

The ClinicalTrials.gov registry entry for NCT01396486 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pediatric Bipolar Spectrum Disorders appearing as the primary indexed condition, and to 2 interventions - of which Omega-3 is the first listed.

NCT01396486 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01396486 about?

NCT01396486 is a clinical study titled "Inositol and Omega-3 Fatty Acids in Pediatric Mania". The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3 fatty acid plus inositol in the treatment of pediatric bipolar disorder, and c) assess the side effect profile of omega-...

What is the current status of trial NCT01396486?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2012-02-03. Estimated completion is 2019-04-11.

What conditions does trial NCT01396486 study?

This clinical trial studies the following conditions: Pediatric Bipolar Spectrum Disorders.

What interventions are being tested in trial NCT01396486?

The interventions under investigation include: Omega-3 (DRUG), Inositol (DRUG).

Who is sponsoring clinical trial NCT01396486?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01396486 being conducted?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.