Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Risperidone oral solution; Valproate Oral Solution; Placebo
Intervention description: liquid, BID dosing.; liquid, BID dosing.; liquid, BID dosing.
Intervention MeSH terms: Valproic Acid; Risperidone; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 3 Years
Maximum age: 7 Years
Healthy volunteers: No
Keywords: child; adolescent; bipolar disorder

Summary:

      The primary aim of this proposal is to conduct a preliminary controlled trial of valproate
      and risperidone in children ages 3-7 yr. with bipolar disorders. A secondary aim is to
      carefully characterize these subjects using clinical rating scales and develop pilot data on
      a very young cohort of children with bipolar disorders that can be used to support an
      application to NIMH for a prospective, longitudinal study that will provide important
      information about the course, medication response, neurobiology and outcome of these
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients, 3-7 years 11 months of age.

          2. Each patient's authorized legal guardian must understand the nature of the study and
             must provide written informed consent. Each patient must also give assent to study
             participation.

          3. Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (DSM-IV) bipolar disorder and must currently display an
             acute manic, hypomanic or mixed episode as determined by DSM-IV criteria. This
             includes the following diagnoses: 296.4x, Bipolar I Disorder, Most Recent Episode
             Manic; 296.6x, Bipolar I Disorder, Most recent Episode Mixed; and 296.0x, Bipolar I
             Disorder, Single Manic Episode, Bipolar II Disorder, Most Recent Episode Hypomanic.

          4. Patients must have an initial score (at day 0) on the YMRS total score of at least 20.

          5. Subjects and their caretakers should be fluent in English.

        Exclusion Criteria:

          1. Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory,
             cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical
             conditions.

          2. Neurologic disorders including epilepsy, stroke, or severe head trauma.

          3. Clinically significant laboratory abnormalities, on any of the following tests: CBC
             with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis,
             thyroid indices (T3, Total T4, Free T4, TSH), and EKG.

          4. Mania due to a general medical condition or substance-induced mania (DSM-IV).

          5. Mental retardation (IQ <70), evidence of Fetal Alcohol Syndrome or an Alcohol-Related
             Neurodevelopmental Disorder.

          6. History of hypersensitivity to or intolerance of risperidone or valproate.

          7. Prior history of risperidone or valproate non-response.

          8. Judged clinically to be at serious suicidal risk.

          9. Participation in a clinical trial of another investigational drug within 1 month (30
             days) prior to study entry.

         10. Treatment with an injectable depot neuroleptic within less than one dosing interval
             between depot neuroleptic injections and day 0.

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