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NCT03757585 · ClinicalTrials.gov registry record · Phase 4
Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT03757585: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT03757585 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 54 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03757585, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 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 with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). Subjects will include youth ages 5-17 years with a non-verbal learning disability (NVLD) or autism spectrum disorder (ASD) and current symptoms of emotional dysregulation.
Interventions
- DRUG Open-label Treatment with Omega-3 Fatty Acids + Inositol
- DRUG Open-label Treatment with N-acetylcysteine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2019-05-20 |
| Est. Completion | 2024-05-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03757585
The ClinicalTrials.gov registry entry for NCT03757585 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 54 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 2 interventions - of which Open-label Treatment with Omega-3 Fatty Acids + Inositol is the first listed.
NCT03757585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03757585 about?
NCT03757585 is a clinical study titled "Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)". 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 with non-verbal learning disability...
What is the current status of trial NCT03757585?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2019-05-20. Estimated completion is 2024-05-06.
What interventions are being tested in trial NCT03757585?
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 NCT03757585?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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