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NCT02357290 · ClinicalTrials.gov registry record · Phase 4
Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT02357290: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT02357290 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02357290, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
Children between the ages of 5-17 years old who have or display symptoms of emotional dysregulation (explosiveness, mood swings, irritability, and/or violent behavior) are invited to participate in a 12-week research study to determine the effectiveness and safety of the natural treatment N-acetylcysteine (NAC) for children with emotional and behavioral problems. After undergoing a comprehensive evaluation by medical doctors with a specialty in this area, children who are found eligible to participate in this research study will be treated with NAC. Following the evaluation period, this research study requires 12 weekly visits, either in our office or over the phone, in an effort to closely monitor each child's response to the medication. Eligible participants will receive study-related evaluations and weekly study visits with our study doctors at no cost.
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.
Interventions
- DRUG Open-label Treatment with N-Acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-01 |
| Est. Completion | 2018-09-24 |
| Phase | Phase 4 |
What the finished NCT02357290 record still lists
NCT02357290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Open-label Treatment with N-Acetylcysteine is the first listed.
NCT02357290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02357290 about?
NCT02357290 is a clinical study titled "Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders". Children between the ages of 5-17 years old who have or display symptoms of emotional dysregulation (explosiveness, mood swings, irritability, and/or violent behavior) are invited to participate in a 12-week research study to determine the effectiveness and safety of the natural treatment N-acetylcy...
What is the current status of trial NCT02357290?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2014-01. Estimated completion is 2018-09-24.
What interventions are being tested in trial NCT02357290?
The interventions under investigation include: Open-label Treatment with N-Acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT02357290?
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 NCT02357290's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 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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