Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Open-label Treatment with N-Acetylcysteine
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: mania; temper tantrum; irritability; mood; bipolar

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, 5-17 years of age

          -  Subjects must have a DSM-IV diagnosis of a bipolar spectrum disorder (type I, II, or
             Not Otherwise Specified) and currently display mixed, manic, or hypomanic symptoms
             (without psychotic features) according to clinical assessment based on the DSM-IV and
             confirmed with structured diagnostic interview

          -  Subjects and their legal representative must have a level of understanding sufficient
             to communicate intelligently with the investigator and study coordinator and to
             cooperate with all tests and examinations required by the protocol

          -  Subjects and their legal representatives must be considered reliable.

          -  Each subject and his/her authorized legal representative must understand the nature of
             the study. The subject's authorized legal representative must provide written consent
             and the subject must provide written assent.

          -  Subjects must have an initial score on the YMRS of at least 15.

        Exclusion Criteria:

          -  Investigator and his/her immediate family (defined as the investigator's spouse,
             parent, child, grandparent, or grandchild)

          -  Serious or unstable illness including hepatic, rental, gastroenterological,
             respiratory, cardiovascular (including ischemic heart disease), endocrinologic,
             neurologic, immunologic, or hematologic disease

          -  Uncorrected hypothyroidism or hyperthyroidism

          -  History of sensitivity to N-acetylcysteine, a history of intolerance to
             N-acetylcysteine, or a non-responder after 2 months of treatment at adequate doses as
             determined by the clinician

          -  Severe allergies or multiple adverse drug reactions

          -  Current or past history of seizures

          -  Active substance abusers, per clinician judgment

          -  Judged clinically to be at serious suicidal risk

          -  Current diagnosis of schizophrenia

          -  Pregnancy

          -  C-SSRS score ≥ 4

          -  IQ < 70