Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
Condition: Pediatric Bipolar Disorder; Pediatric OCD
MeSH terms: Bipolar Disorder; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: fluoxetine
Intervention description: capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks
Intervention MeSH terms: Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: bipolar disorder; obsessive compulsive disorder; Prozac

Summary:

      This will be a 12-week open-label pilot treatment study for children and adolescents (ages
      6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder
      (OCD) who are adequately mood stabilized on a stable regimen based on standard clinical care.
      Specific hypotheses are as follows:

      Hypothesis 1: Children and adolescents with comorbid OCD and BPD who have achieved adequate
      mood stabilization using a naturalistic clinical practice approach, will benefit from an
      FDA-approved selective seratonin reuptake inhibitor (SSRI) on their OCD symptoms in a
      clinically meaningful way without exacerbation of bipolar symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants between 6 and 17 years of age.

          -  Participants must have DSM-IV diagnosis of OCD and bipolar (I or II) disorder,
             displaying current OCD symptoms of at least moderate impairment (CY-BOCS ≥ 15) and for
             at least 4 weeks prior to participation maintained on steady dose of mood stabilizing
             medication (lithium, anticonvulsants or atypical antipsychotics) with minimal or mild
             mood symptoms (YMRS ≤ 15). Period of mood stabilization will be determined by
             clinician judgment and confirmed by K-SADS-E.

          -  Subject and his/her 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 his/her legal representative 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 and the subject must sign an
             IRB approved informed consent and assent document respectively.

          -  Subject must be able to participate in mandatory blood draws.

          -  Subject must be able to swallow pills.

          -  Subjects with comorbid ADHD, ODD, CD, or other anxiety disorders will be allowed to
             participate in the study provided they do not meet any exclusionary criteria.

        Exclusion Criteria:

          -  DSM-IV substance dependence (except nicotine or caffeine) within past 3 months.

          -  History of anti-depressant induced mania or hypomania while also being treated with
             appropriate dosage(s) of mood stabilizers.

          -  Pregnant or nursing females.

          -  Investigator and his/her immediate family, defined as the investigator's spouse,
             parent, child, grandparent, or grandchild.

          -  Serious, unstable systemic illness.

          -  History of severe allergies or multiple adverse drug reactions.

          -  Non-febrile seizures without a clear and resolved etiology.

          -  Clinically judged to be at serious suicidal risk.

          -  Other concomitant medication with primary central nervous system activity other than
             those specified in the Concomitant Medication protocol.

          -  History of allergic reaction to SSRIs.

          -  Participants using an MAOI within two weeks prior to receiving study medication.

          -  Current diagnosis of schizophrenia.

          -  Uncorrected hypo or hyperthyroidism.

          -  Active symptoms of anorexia or bulimia nervosa

          -  Non-response of OCD symptoms to fluoxetine as defined by being on therapeutic dose of
             fluoxetine for at least 10 weeks.

          -  Current treatment with antidepressant medication.