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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: Completed Phase 4 study of Pediatric Bipolar Spectrum Disorders, sponsored by Massachusetts General Hospital.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Young Mania Rating Scale (YMRS) consists of 7 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe) and 4 items rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe).The YMRS score ranges from 0-60. Questions are asked about the last week. A higher score signifies more severe manic symptoms.
Conditions Studied
Interventions
- DRUG Omega-3
- DRUG Inositol
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2012-02-03 |
| Est. Completion | 2019-04-11 |
| Phase | Phase 4 |
What the finished NCT01396486 record still lists
NCT01396486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01396486's enrollment target sits among peer trials
69 1070th of 2000 higher than 925 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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