Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents
Condition: Pediatric Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Aripiprazole; fish oil; Placebo
Intervention description: tablet, start at 2mg and increase/decrease each week, taken daily for 12 weeks; 1600mg (4 capsules) daily for 12 weeks; Placebo
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: bipolar disorder; fish oil; aripiprazole; children

Summary:

      This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to
      open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV
      criteria for bipolar disorder (BPD) (currently manic or mixed). Specific hypotheses are as
      follows:

      Hypothesis 1: Omega-3 fatty acids will be well-tolerated and efficacious in the treatment of
      children and adolescents with BPD

      Hypothesis 2: The total dose of aripiprazole will be lower in those subjects receiving active
      omega-3 treatment
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject, 6-17 years of age

          2. Subject has a DSM-IV diagnosis of bipolar I, bipolar II, or bipolar spectrum disorder
             and currently displaying manic, hypomanic, or mixed symptoms (with or without
             psychotic features)

          3. Subject and their legal representative 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

          4. Subject and their legal representative must be considered reliable

          5. Subject and his/her authorized legal representative must understand the nature of the
             study. The subject's authorized legal representative must sign an informed consent
             document and the subject must sign an informed assent document

          6. Subject must have an initial score on the Young-Mania Rating Scale (Y-MRS) of at least
             20

          7. Subject must be able to participate in mandatory blood draws

          8. Subject must be able to swallow pills

          9. Subjects with comorbid Attention Deficit Hyperactivity Disorder (ADHD), Oppositional
             Defiant Disorder (ODD), Conduct Disorder (CD), Obsessive Compulsive Disorder (OCD),
             Pervasive Developmental Disorders (PDD), anxiety and depressive disorders will be
             allowed to participate in the study provided they do not meet for any of exclusionary
             criteria

         10. For concomitant therapy used to treat ADHD, subject must have been on a stable dose of
             the medication for 1 month prior to study enrollment. The dose of the ADHD therapy may
             not change throughout the duration of the study.

        Exclusion Criteria:

          1. Investigator and his/her immediate family; defined as the investigator's spouse,
             parent, child, grandparent, or grandchild

          2. Serious, unstable illness including heptic, renal, gastroenterological, respiratory,
             cardiovascular (including ischemic heart disease), endocrinologic, neurologic,
             immunologic, or hematologic disease

          3. Uncorrected hypothyroidism or hyperthyroidism

          4. History of sensitivity to omega-3 fatty acids. A non-responder or history of
             intolerance to omega-3 fatty acid, after treatment at adequate doses as determined by
             the clinician.

          5. Severe allergies or multiple adverse drug reactions.

          6. Non-febrile seizures without a clear and resolved etiology

          7. DSM-IV substance (except nicotine or caffeine) dependence within past 6 months

          8. Judged clinically to be at serious suicidal risk

          9. Any other concomitant medication with primarily central nervous system activity other
             than specified in the Concomitant Medication portion of the protocol.

         10. Current diagnosis of schizophrenia

         11. Pregnant or nursing females