drugset / Trial / NCT03911414
A Clinical Trial Via Telepsychiatry of Treatments for the Management of Emotional Dysregulation in Youth
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-06-18
- Primary completion
- 2024-12-04
- Completion
- 2024-12-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inositol | Small molecule | 1000 mg | — |
| Subject | Inositol | Small molecule | 2000 mg | — |
| Subject | N-acetylcysteine | Small molecule | 1800 mg | — |
| Subject | N-acetylcysteine | Small molecule | 2400 mg | — |
| Subject | N-acetylcysteine | Small molecule | 2700 mg | — |
| Subject | Omega-3 fatty acids | Unknown | 1020 mg | — |