Body Dysmorphic DisorderPhase 4FDA BDDNCT00245635
Fluoxetine in Pediatric Body Dysmorphic Disorder
A Phase 4 study testing Fluoxetine in people with Body Dysmorphic Disorder, run by Montefiore Medical Center at 2 sites in United States.
Trial summary
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Body Dysmorphic Disorder
- What is being tested?
- Fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2004to Apr 2012
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female children and adolescents aged 16 and younger
- BDD or its delusional variant present currently and for at least 6 months prior to the study
- Ability to communicate meaningfully with the investigators and competent to provide written assent
Who cannot join
- Presence of Schizophrenia or Bipolar Disorder
- Recent suicide attempt or suicidal ideations that warrant hospitalizations
- Previous allergic reaction to fluoxetine
- History of a seizure disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Hospital
Providence, Rhode Island, 02903
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, 10467
About this study
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
Read the detailed description
BDD usually begins in childhood or adolescence, but its treatment in pediatric populations has not been investigated. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs) such as fluoxetine (Prozac). Preliminary findings from case reports suggest that SRIs may also be effective in the treatment of BDD in children and adolescents. This study is the first large-scale, double-blind, placebo-controlled medication trial of fluoxetine for children and adolescents with BDD. Participants should be aged 16 or younger. Participation in this trial will last approximately 14 weeks.
- Conditions
- Body Dysmorphic Disorder
- Being tested
- Fluoxetine, Placebo
- Keywords
- Body Dysmorphic Disorder, BDD, BDD treatment, delusionality variant, OCD
- Medical subject headings
- Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac
Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.
PlaceboDrug
Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day. Receives: Drug: Fluoxetine |
| Placebo | Placebo comparator | Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Score on the BDD-Y-BOCS Scale
To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.
Measured: Baseline compared to the study endpoint (week 12) [two time points]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startNov 2004
- Primary completionApr 2012
- Study completionApr 2012
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 Body Dysmorphic DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Eric Hollander, Montefiore Medical Center
- Investigators
- Eric Hollander, MD, Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245635
- Sponsor's protocol ID
- 09-10-302
- Other IDs
- 7R01FD002613-04
- Acronym
- FDA BDD
- Status last verified
- Mar 2018
- First submitted
- 26 Oct 2005
- Last updated
- 27 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoxetine in Pediatric Body Dysmorphic Disorder
- ClinicalTrials.gov ID
- NCT00245635
- Acronym / sponsor ID
- FDA BDD / 09-10-302
- Conditions
- Body Dysmorphic Disorder
- Keywords
- Body Dysmorphic Disorder, BDD, BDD treatment, delusionality variant, OCD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- Nov 2004
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Oct 2005 (estimated)
- Results
- Posted 29 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
Detailed description
BDD usually begins in childhood or adolescence, but its treatment in pediatric populations has not been investigated. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs) such as fluoxetine (Prozac). Preliminary findings from case reports suggest that SRIs may also be effective in the treatment of BDD in children and adolescents. This study is the first large-scale, double-blind, placebo-controlled medication trial of fluoxetine for children and adolescents with BDD. Participants should be aged 16 or younger. Participation in this trial will last approximately 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Experimental | Drug: FluoxetineFixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female children and adolescents aged 16 and younger
- BDD or its delusional variant present currently and for at least 6 months prior to the study
- Ability to communicate meaningfully with the investigators and competent to provide written assent
Key exclusion criteria (4 listed)
- Presence of Schizophrenia or Bipolar Disorder
- Recent suicide attempt or suicidal ideations that warrant hospitalizations
- Previous allergic reaction to fluoxetine
- History of a seizure disorder
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: ProzacTablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score. | Drug | Fluoxetine |
| PlaceboPlacebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score. | Drug | Placebo |
Primary outcome
Change in Total Score on the BDD-Y-BOCS Scale
Time frame: Baseline compared to the study endpoint (week 12) [two time points]
To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- 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.
Eric Hollander, MD principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
2 sites 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 Body Dysmorphic Disorder, run by Montefiore Medical Center at 2 sites 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 29 Jun 2015). 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?
Change in Total Score on the BDD-Y-BOCS Scale (time frame: Baseline compared to the study endpoint (week 12) [two time points]). 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 27 Apr 2018.