Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Slow subject recruitment.)
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592852
First received: December 28, 2007
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Pediatric Bipolar Disorder
Pediatric OCD
Drug: fluoxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: weekly ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: weekly ] [ Designated as safety issue: No ]
    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.


Enrollment: 13
Study Start Date: December 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluoxetine Drug: fluoxetine
capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks
Other Name: Prozac

Detailed Description:

As no systemic data is available regarding the efficacy and safety of selective serotonin reuptake inhibitors (SSRI) in the treatment of OCD+BPD children, it calls for a preliminary open pilot treatment study to explore these issues as a logical first step that could lead to systematic randomized controlled trials in the future. SSRI's are the first line and most commonly used anti-OCD agents. It remains unknown, which of the standard SSRIs is least activating for youth with BPD. Fluoxetine along with fluvoxamine and sertraline are FDA approved for the treatment of OCD in children. Fluoxetine remains the most extensively studied SSRI in children. We will test the safety and efficacy of fluoxetine in children and adolescents with BPD and OCD.

The proposed study includes 1.) the use of a 12-week design to document the response rate and 2.) careful assessment of safety and tolerability

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592852

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Gagan Joshi, MD MGH
  More Information

Additional Information:
No publications provided

Responsible Party: Gagan Joshi, MD, Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592852     History of Changes
Other Study ID Numbers: 2005-P-001840
Study First Received: December 28, 2007
Results First Received: July 28, 2011
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
bipolar disorder
obsessive compulsive disorder
Prozac

Additional relevant MeSH terms:
Bipolar Disorder
Compulsive Personality Disorder
Disease
Obsessive-Compulsive Disorder
Affective Disorders, Psychotic
Anxiety Disorders
Mental Disorders
Mood Disorders
Pathologic Processes
Personality Disorders
Fluoxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014