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

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Fluoxetine

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.