drugset / Trial / NCT02357290

Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders

NCT02357290

Phase 4 Completed 40 enrolled Massachusetts General Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-01
Primary completion
2018-09-24
Completion
2018-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 900 mg Oral
Subject N-acetylcysteine Small molecule 1800 mg Oral

Indications