Pediatric Bipolar DisorderPhase 4NCT00592852
Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
A Phase 4 study testing fluoxetine in people with Pediatric Bipolar Disorder and Pediatric OCD, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pediatric Bipolar Disorder, Pediatric OCD
- What is being tested?
- fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
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.
Read the 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
- Conditions
- Pediatric Bipolar Disorder, Pediatric OCD
- Being tested
- fluoxetine
- Keywords
- bipolar disorder, obsessive compulsive disorder, Prozac
- Medical subject headings
- Bipolar Disorder, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoxetineDrug
Also called Prozac
capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | Not described Receives: Drug: fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: weekly
Secondary outcomes (1)
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.
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startDec 2005
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Slow subject recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gagan Joshi, Massachusetts General Hospital
- Investigators
- Gagan Joshi, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592852
- Sponsor's protocol ID
- 2005-P-001840
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2007
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Treatment Study of Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00592852
- Acronym / sponsor ID
- 2005-P-001840
- Conditions
- Pediatric Bipolar Disorder, Pediatric OCD
- Keywords
- bipolar disorder, obsessive compulsive disorder, Prozac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow subject recruitment.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Posted 6 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Experimental | Drug: fluoxetine |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluoxetineAlso: Prozaccapsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks | Drug | Fluoxetine |
Primary outcome
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time frame: 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).
1 secondary outcome
Young Mania Rating Scale (YMRS)
Time frame: weekly
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gagan Joshi, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluoxetine in people with Pediatric Bipolar Disorder and Pediatric OCD, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) (time frame: weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.