Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fluoxetine
|
Drug: fluoxetine
capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [weekly]
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) [weekly]
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.
Eligibility Criteria
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.
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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.
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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.
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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.
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Pregnant or nursing females.
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Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild.
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Serious, unstable systemic illness.
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History of severe allergies or multiple adverse drug reactions.
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Non-febrile seizures without a clear and resolved etiology.
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Clinically judged to be at serious suicidal risk.
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Other concomitant medication with primary central nervous system activity other than those specified in the Concomitant Medication protocol.
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History of allergic reaction to SSRIs.
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Participants using an MAOI within two weeks prior to receiving study medication.
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Current diagnosis of schizophrenia.
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Uncorrected hypo or hyperthyroidism.
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Active symptoms of anorexia or bulimia nervosa
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Cambridge | Massachusetts | United States | 02138 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Gagan Joshi, MD, MGH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2005-P-001840
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Fluoxetine |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 13 |
| COMPLETED | 7 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | Fluoxetine |
|---|---|
| Arm/Group Description | |
| Overall Participants | 13 |
| Age (Count of Participants) | |
| <=18 years |
12
92.3%
|
| Between 18 and 65 years |
1
7.7%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
12.46
(3.91)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
30.8%
|
| Male |
9
69.2%
|
| Region of Enrollment (participants) [Number] | |
| United States |
13
100%
|
Outcome Measures
| Title | Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) |
|---|---|
| Description | 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). |
| Time Frame | weekly |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment. |
| Arm/Group Title | Fluoxetine |
|---|---|
| Arm/Group Description | |
| Measure Participants | 11 |
| Mean (Standard Deviation) [Units on a scale] |
14.18
(9.98)
|
| Title | Young Mania Rating Scale (YMRS) |
|---|---|
| Description | 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. |
| Time Frame | weekly |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment. |
| Arm/Group Title | Fluoxetine |
|---|---|
| Arm/Group Description | |
| Measure Participants | 11 |
| Mean (Standard Deviation) [Units on a scale] |
13
(12.54)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Fluoxetine | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Fluoxetine | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Fluoxetine | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Fluoxetine | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/11 (72.7%) | |
| Ear and labyrinth disorders | ||
| dizziness | 2/11 (18.2%) | 3 |
| Eye disorders | ||
| blurred vision (distance) | 1/11 (9.1%) | 1 |
| Gastrointestinal disorders | ||
| nausea | 1/11 (9.1%) | 1 |
| vomiting | 1/11 (9.1%) | 1 |
| General disorders | ||
| chest uneasiness | 1/11 (9.1%) | 1 |
| decreased appetite | 1/11 (9.1%) | 1 |
| drooling | 1/11 (9.1%) | 3 |
| headache | 2/11 (18.2%) | 4 |
| increased appetite | 3/11 (27.3%) | 8 |
| irritable | 1/11 (9.1%) | 1 |
| nose bleed | 1/11 (9.1%) | 1 |
| runny nose | 1/11 (9.1%) | 1 |
| sleep disturbance | 1/11 (9.1%) | 1 |
| tiredness | 3/11 (27.3%) | 3 |
| Injury, poisoning and procedural complications | ||
| hurt cheek playing soccer | 1/11 (9.1%) | 1 |
| Psychiatric disorders | ||
| worsening of manic symptoms | 3/11 (27.3%) | 3 |
| Renal and urinary disorders | ||
| frequent urination | 1/11 (9.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| bilateral medial thigh skin lesion | 1/11 (9.1%) | 1 |
| eczema rash | 1/11 (9.1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Gagan Joshi, MD |
|---|---|
| Organization | Massachusetts General Hospital |
| Phone | 617-503-1084 |
| joshi.gagan@mgh.harvard.edu |
- 2005-P-001840