Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder

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) andfor at least 4 weeks prior to participation maintained on steady dose of moodstabilizing medication (lithium, anticonvulsants or atypical antipsychotics) withminimal or mild mood symptoms (YMRS ≤ 15). Period of mood stabilization will bedetermined by clinician judgment and confirmed by K-SADS-E.

• Subject and his/her legal representative must have a level of understandingsufficient 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 natureof the study. The subject's authorized legal representative and the subject mustsign 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 toparticipate 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 withappropriate 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 thanthose 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 doseof fluoxetine for at least 10 weeks.

• Current treatment with antidepressant medication.