Fluoxetine in Pediatric Body Dysmorphic Disorder
Do you know any children or teenagers with excessive appearance concerns? Do they spend a lot of time worrying about the way they look? Are they upset by their appearance? Do they spend a lot of time fixing or covering up features that they don’t like? Do they avoid activities because of their appearance?
If you answered yes to any of these questions, this child or teenager may qualify for a no-cost evaluation and research study involving medication for children and adolescents (16 years old and younger) at Rhode Island Hospital.
1) Male or female subjects, ages 16 years 11 months old and younger;
2) A diagnosis of DSM-IV BDD or its delusional variant must be present currently and for at least 6 months prior to study entry. As specified by DSM-IV criteria for BDD, the bodily preoccupation must not be better accounted for by another Axis I disorder (e.g., an eating disorder, gender identity disorder);
3) A total score of at least 24 on the 12-item Yale-Brown Obsessive-Compulsive Scale Modified for BDD (BDD-YBOCS) (1), which includes a score of at least 2 on item 1 (1-3 hours/day of preoccupation with the perceived defect);
4) A score of at least moderate on the Clinical Global Impressions of Severity (CGI-Severity) scale (2);
5) A score of <60 on the Child Global Assessment Scale (C-GAS) (3,4);
6) Ability to communicate meaningfully with the investigators and competent to provide written assent; both parental informed consent and adolescent assent must be obtained.
1) Schizophrenia, schizoaffective disorder, or any other current or lifetime DSM-IV psychotic disorder that is not attributable to delusional BDD (delusional disorder, somatic type);
2) Current or lifetime DSM-IV bipolar disorder;
3) Current or recent (within 2 months of study entry) DSM-IV alcohol or substance dependence or abuse or a positive urine drug screen for any illicit substances of abuse (In the event of a positive drug screen, the study doctor will discuss the findings with the child. If in the study doctor’s opinion the child is at risk of harm because of the substance use, s/he will break confidentiality and discuss the findings with the parents/guardian of the child. Otherwise, confidentiality will not be broken and the parents/guardian will not be made aware of the positive drug screen);
4) Recent (within the past 6 months) suicide attempt, or suicidal ideation as indicated by a K-SADS score of 4 or higher that is active or warrants consideration of hospitalization;
5) Need for inpatient or partial hospital treatment;
6) Past treatment with fluoxetine unless the trial consisted of 40 mg/day or less for 8 weeks or less;
7) Use of any psychoactive medication or herbal preparations with alleged behavioral effects (e.g., valerian, St. John’s wort, melatonin) within 3 weeks (6 weeks for fluoxetine) prior to initiation of placebo;
8) Requirement for any psychotropic medications or medications which, in the investigators’ judgment, might interact unfavorably with fluoxetine. This includes cardiovascular medications including warfarin, antimigraine compounds, narcotics, any illicit drugs, over-the-counter sympathomimetic cold preparations (e.g., pseudoephedrine, phenylephrine, phenylpropanolamine), xanthine bronchodilators, sibutramine, or antihistamines except for Allegra, Claritin, and Tavist; individuals who have been on a stable dose of the following medications for at least 6 weeks will be entered into the trial: stimulants, alpha2 antagonists, anticonvulsants (excluding carbamazepine and phenytoin), and low dose trazodone for sleep. Individuals on another antidepressant, an antipsychotic, a benzodiazepine, or buspirone will not be allowed into the study even on a stable dose, as these medications could potentially affect BDD symptoms;
9) Use of any investigational medication within 3 months or a depot neuroleptic within 6 months;
10) Previous allergic reaction (e.g., rash) to fluoxetine;
11) Current cognitive-behavioral therapy or psychotherapy (group, family, or individual insight-oriented psychotherapy) or initiation of supportive psychotherapy within 3 months prior to baseline;
12) Presence of any significant and/or unstable gastrointestinal, neurologic, endocrine, cardiovascular, renal, pulmonary, hepatic, immunologic, hematologic, or other systemic disease; cancer; or organic brain syndrome as determined by history, physical examination, or EKG or laboratory results. Subjects with a stable medical condition may participate if, in the investigators’ judgment, fluoxetine would not adversely affect the condition and provided no medications are being taken for the condition that might interact adversely with fluoxetine. In all such cases, subjects will enter the study with the agreement of their treating physician;
13) History of a seizure disorder;
14) Females who are pregnant or breast-feeding or who are sexually active and not using adequate contraception (e.g., oral contraceptive, intrauterine device, implant, Depo-Provera, or barrier devices);
15) Clinically significant abnormal EKG or laboratory tests; subjects must be euthyroid;
16) Presence of any behavior (e.g., violence) that would interfere with full cooperation with the protocol.