Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder
Condition: Pediatric Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: paliperidone
Intervention description: tablet, 3mgQAM - 6mgQAM, taken daily for 8 weeks
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: bipolar disorder; children; adolescents; Invega

Summary:

      This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the
      treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or
      Bipolar Spectrum Disorder. Specific hypotheses are as follows:

      Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar
      I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.

      Hypothesis 2: Invega -associated improvement in bipolar disorder symptomatology in children
      and adolescents will translate into improved functional capacities (neuropsychological,
      social, and occupational), as well as an increased quality of life throughout treatment.

      Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out
      rate and absence of major side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female outpatients 6-17 years of age (inclusive).

          2. Subjects with the diagnosis of Bipolar or Bipolar Spectrum Disorder and currently
             displaying manic, hypomanic, or mixed symptoms (with or without psychotic features),
             by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
             Bipolar Spectrum Disorder (or sub- threshold bipolar disorder) is operationalized as
             having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but
             display fewer elements in Criteria B (only require 2 items for elation category and 3
             for irritability).

          3. Subjects must score ≥ 20 on the YMRS.

          4. 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.

          5. Subjects and their legal representative must be considered reliable reporters.

          6. Each 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 (if ≥ 7 years old).

          7. Subject must be able to participate in mandatory blood draws.

          8. Subject must be able to swallow pills.

          9. Subjects with comorbid Oppositional Defiant Disorder (ODD), Conduct Disorder (CD),
             Obsessive-Compulsive Disorder (OCD), Pervasive Developmental Disorder (PDD), anxiety
             and depressive disorders will be allowed to participate in the study provided they do
             not meet for any of the exclusionary criteria.

         10. For concomitant therapy used to treat ADHD, subjects must have been on a stable dose
             of the medication for 1 month prior to study enrollment. The dose of the ADHD therapy
             will 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 hepatic, renal, gastroenterological, respiratory,
             cardiovascular (including ischemic heart disease), endocrinologic, neurologic,
             immunologic, or hematologic disease.

          3. Uncorrected hypothyroidism or hyperthyroidism.

          4. Non-febrile seizures without a clear and resolved etiology.

          5. DSM-IV substance (except nicotine or caffeine) dependence within past 6 months.

          6. Judged clinically to be at serious suicidal risk.

          7. Any other concomitant medication with primary central nervous system activity other
             than specified in the Concomitant Medication portion of the protocol.

          8. Current diagnosis of schizophrenia.

          9. Mental retardation (IQ < 75).

         10. Pregnant or nursing females.

         11. Known hypersensitivity to Invega® or similar formulations (paliperidone, risperidone).

         12. A non-responder or history of intolerance to Invega®, after treatment at adequate
             doses as determined by the clinician.

         13. Severe allergies or multiple adverse drug reactions.

         14. Subjects with a hematological disorder.

         15. Subjects with diabetes.