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NCT03911414 · ClinicalTrials.gov registry record · Phase 4
A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT03911414: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT03911414 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03911414, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents (ages 5-17). Subjects will be randomized to one of two arms: 1) omega-3 fatty acids plus inositol or 2) NAC.
Primary Outcome
The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). It is used to assess manic symptoms. Scores from each item are summed to obtain the total YMRS score. The YMRS score ranges from 0-60. A higher score means a higher manic state. Questions are asked about the last week. This scale is generally accepted as the main outcome measure in studies of pediatric bipolar disorder and is linked directly to the core symptoms of mania.
Interventions
- DRUG Open-label Treatment with Omega-3 Fatty Acids + Inositol
- DRUG Open-label Treatment with N-acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-06-18 |
| Est. Completion | 2024-12-04 |
| Phase | Phase 4 |
What the finished NCT03911414 record still lists
NCT03911414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Open-label Treatment with Omega-3 Fatty Acids + Inositol is the first listed.
NCT03911414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03911414 about?
NCT03911414 is a clinical study titled "A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth". This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents (ages 5-17). Subjects will be rando...
What is the current status of trial NCT03911414?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2019-06-18. Estimated completion is 2024-12-04.
What interventions are being tested in trial NCT03911414?
The interventions under investigation include: Open-label Treatment with Omega-3 Fatty Acids + Inositol (DRUG), Open-label Treatment with N-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT03911414?
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 NCT03911414's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 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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