Pediatric Bipolar Disorder Clinical Trial
Official title:
A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 17 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | This sale measures impairment on 5 items relating to Obsessions from 0 (none) to 4 (extreme) and 5 item relating to Compulsions from 0 (none) to 4 (extreme). These scores are totaled for a range of 0 (least impaired) to 40 (most impaired). | weekly | No |
Secondary | Young Mania Rating Scale (YMRS) | This scale measures mania symptoms in children and adolescents using 11 items rated from 0 (least severe) to 4 (most severe), although 4 items are rated from 0-8. The minimum (least severe) possible score is 0, and the maximum (most severe) possible score is 60. | weekly | No |
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