CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Open-label Treatment with N-Acetylcysteinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02357290
NCT02357290Phase 4Completed

Open-Label Study of N-Acetylcysteine in Children and Adolescents Ages 5-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder

Massachusetts General Hospital·interventional·Posted Feb 6, 2015·Updated Nov 4, 2019

In Brief

A Phase 4 clinical trial evaluating Open-label Treatment with N-Acetylcysteine for Bipolar Disorder. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2015
Enrollment StartJan 1, 2014
Primary CompletionSep 24, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.4 years ago

Interventions

Open-label Treatment with N-Acetylcysteinedrug