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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02357290
The ClinicalTrials.gov registry entry for NCT02357290 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 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 0 conditions, and to 1 intervention - of which Open-label Treatment with N-Acetylcysteine is the first listed.
NCT02357290 reports 0 study locations.
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.
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