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

Stopped early · Phase 4

Conditions studied: Pediatric Bipolar Disorder, Pediatric OCD

In brief

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.

Key facts

Study ID: NCT00592852
Run by: Massachusetts General Hospital
People needed: 13
Starts: 2005-12-01
Expected to finish: 2010-09-01
Last updated by the study team: 2025-01-28

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Massachusetts General Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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