Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
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|ClinicalTrials.gov Identifier: NCT02357290|
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Open-label Treatment with N-Acetylcysteine||Phase 4|
This will be a 12-week, open-label study of NAC in the treatment of bipolar disorder in children and adolescents. Subjects will include youth ages 5-17 years with a bipolar spectrum disorder (type I, II, or NOS), mixed, manic, or hypomanic state, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-5 (American Psychiatric Association, 2013). The primary outcome measures will be improvement in manic symptoms as measured by the Young Mania Rating Scale (YMRS) and improvement in depressive symptoms as measured by the Child Depression Rating Scale (CDRS).
Bipolar diagnoses will be made according to the DSM-5 in a clinical evaluation by a Child Psychiatrist and confirmed using the Schedule for Affective Disorders and Schizophrenia for School-Age Children - Epidemiological Version (K-SADS-E)(Orvaschel, 1994). All subjects must have a YMRS score of at least 15. Only patients who are not responding to their current treatment regimen will be tapered from their medications; youth on concomitant psychiatric medications will be permitted to continue those medications as listed in the concomitant medication section.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Study of N-Acetylcysteine in Children and Adolescents Ages 5-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 24, 2018|
|Actual Study Completion Date :||September 24, 2018|
Experimental: Open-label Treatment with NAC
12-week, open-label treatment with NAC. Subjects will be treated with the following dose:
Subjects ages 5-12:
Week 1: 900mg po daily Weeks 2+: 900mg po QAM, 900mg po QPM
Subjects ages 13-17:
Week 1: 900mg po daily Weeks 2-3: 900mg po QAM, 900mg po QPM Weeks 4+: 1800mg po QAM, 900mg po QPM
In Weeks 3-12 for subjects ages 13-17, we will encourage twice per day dosing, but we will permit daily dosing if needed for adherence.
Drug: Open-label Treatment with N-Acetylcysteine
- Mean Change in the Young Mania Rating Scale (YMRS) Score [ Time Frame: 12 Weeks ]The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). It is used to assess manic symptoms.
- Mean Change in the Children's Depression Rating Scale (CDRS) Score [ Time Frame: 12 Weeks ]The CDRS is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal. The scale is used to assess childhood depression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357290
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Janet Wozniak, MD||Massachusetts General Hospital|