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

NCT00592852 | Terminated Phase 4 Results

• 1 other identifier: 2005-P-001840
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Bipolar Disorder; Pediatric OCD

Keywords

bipolar disorder; obsessive compulsive disorder; Prozac

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  weekly

Study Arms (1)

Fluoxetine

EXPERIMENTAL

Drug: fluoxetine

Interventions

fluoxetine DRUG

capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks

Also known as: Prozac

Fluoxetine

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Obsessive-Compulsive Disorder

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Gagan Joshi, MD
• Organization: Massachusetts General Hospital

joshi.gagan@mgh.harvard.edu

617-503-1084

Study Officials

• Gagan Joshi, MD

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: December 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 28, 2025
• Results First Posted: March 6, 2012

Record last verified: 2025-01

Locations

US (1)