Back to results

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

Primary Purpose

Pediatric Bipolar Disorder, Pediatric OCD

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

fluoxetine

About this trial

This is an interventional treatment trial for Pediatric Bipolar Disorder focused on measuring bipolar disorder, obsessive compulsive disorder, Prozac

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluoxetine

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00592852

First Posted

December 28, 2007

Last Updated

November 13, 2012

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00592852

Brief Title

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

Official Title

A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Why Stopped

Slow subject recruitment.

Study Start Date

December 2005 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Bipolar Disorder, Pediatric OCD

Keywords

bipolar disorder, obsessive compulsive disorder, Prozac

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluoxetine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

fluoxetine

Other Intervention Name(s)

Prozac

Intervention Description

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

Primary Outcome Measure Information:

Title

Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

Description

Time Frame

weekly

Secondary Outcome Measure Information:

Title

Young Mania Rating Scale (YMRS)

Description

Time Frame

weekly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gagan Joshi, MD

Organizational Affiliation

MGH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02138

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs