| ID | Type | Description | Link |
|---|---|---|---|
| 7R01FD002613-04 | U.S. FDA Grant/Contract | View source |
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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
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This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline compared to the study endpoint (week 12) [two time points] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Hollander, MD | Montefiore Medical Center/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center, Albert Einstein College of Medicine | The Bronx | New York | 10467 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoxetine | Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day. Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score. |
| FG001 | Placebo | Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug. Placebo: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluoxetine | Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day. Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to the study endpoint (week 12) [two time points] |
|
Adverse Event data was collected throughout the course of the study.
Documentation of AE's were supplemented by checklists including the Fluoxetine Side Effects Scale and the SMURF.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluoxetine | Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day. Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Behavior | Psychiatric disorders | Systematic Assessment | Suicidal behavior was seen in one subject and had a possible relationship to study drug, and subject was seen in a partial hospitalization setting. This was reported to the IRB, FDA and DSMB. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Hollander, MD | Montefiore Medical Center, Albert Einstein College of Medicine | 7189204287 | eholland@montefiore.org |
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| ID | Term |
|---|---|
| D057215 | Body Dysmorphic Disorders |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 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. |
|
| Rhode Island Hospital |
| Providence |
| Rhode Island |
| 02903 |
| United States |
| Placebo |
Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug. Placebo: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BDD-Y-BOCS | Total scores at Baseline on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo | Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug. Placebo: 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. |
|
|
| 1 |
| 25 |
| 2 |
| 25 |
| EG001 | Placebo | Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug. Placebo: 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. | 0 | 18 | 3 | 18 |
|
| Weight Loss | Metabolism and nutrition disorders | Systematic Assessment |
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| Trouble Sleeping | Nervous system disorders | Systematic Assessment |
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| Nightmares | Nervous system disorders | Systematic Assessment |
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| Stomach Pains | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Sweating | Endocrine disorders | Systematic Assessment |
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| Agitated/Restlessness | Psychiatric disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
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| Silliness/Feeling too happy | Psychiatric disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Lit Paper on Fire | Social circumstances | Systematic Assessment |
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| Emotional | Psychiatric disorders | Systematic Assessment |
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| Menstrual Cramps | Reproductive system and breast disorders | Systematic Assessment |
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| Forgetfulness | Psychiatric disorders | Systematic Assessment |
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| Light hurts eyes | Eye disorders | Systematic Assessment |
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| Feeling tense | Psychiatric disorders | Systematic Assessment |
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| Ears ringing | Ear and labyrinth disorders | Systematic Assessment |
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| Drowsiness | General disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Blurred/double Vision | Eye disorders | Systematic Assessment |
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| Visit to ER: Family Conflict | Social circumstances | Systematic Assessment |
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| Visit to ER: Aches | General disorders | Systematic Assessment |
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| Itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Leg Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hair Loss | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Delay in Urination | Renal and urinary disorders | Systematic Assessment |
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| Numbness | Nervous system disorders | Systematic Assessment | Hands and feet. |
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| Tingling | Nervous system disorders | Systematic Assessment | Hands and Feet |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Heart Pounding/Racing | Cardiac disorders | Systematic Assessment |
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| Trouble Keeping Balance | Nervous system disorders | Systematic Assessment |
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| Room Spinning | Nervous system disorders | Systematic Assessment |
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| Weight Gain | Metabolism and nutrition disorders | Systematic Assessment |
|
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