Fluoxetine Promising for Pediatric Body Dysmorphic Disorder

Megan Brooks

May 19, 2015

TORONTO ― The selective serotonin reuptake inhibitor (SSRI) fluoxetine (multiple brands), a first-line treatment for adults with body dysmorphic disorder (BDD), may also help in pediatric BDD, results of the first placebo-controlled trial in adolescents suggest.

"Overall, there wasn't a statistically significant change in the primary outcome measure, the BDD-YBOCS [Yale-Brown Obsessive Compulsive Scale], but there was a numerical improvement," Eric Hollander, MD, director, Autism and Obsessive Compulsive Spectrum Program, Montefiore Medical Center, New York City, told Medscape Medical News.

"We think we are getting a trend in the right direction, but we would have needed to recruit an even larger sample in order for that difference between drug and placebo to be statistically significant," he said.

The study was presented here at the American Psychiatric Association (APA) 2015 Annual Meeting.

Neglected Cousin of OCD

BDD shares many features of obsessive-compulsive disorder (OCD). The hallmark of the disorder is a preoccupation with an imagined or slight defect in appearance. The disorder often begins during childhood or adolescence, but until now, no studies of drug therapy for BDD in adolescents have been conducted.

Dr Hollander and a multicenter team enrolled 44 primarily white children aged 18 years and younger with a DSM-IV diagnosis of BDD into their study. Inclusion criteria included a score of ≥24 on the BDD-YBOCS, no previous treatment with fluoxetine, and no concurrent psychotherapy.

"The mean age of the study population was just under 15 years, and the age of onset was around puberty, age 12 or 13, when their bodies are rapidly changing and they are very concerned about fitting in with their peers," said Dr Hollander.

The illness was "pretty severe" in this population, and it had some impact on their academic and social function. "Some refused to go to school, some became homebound," he noted.

After a 1-week single-blind placebo lead-in period, participants who did not significantly improve were randomly assigned to 12 weeks of fluoxetine (weight-based flexible dosing up to a maximum of 60 mg/day) or placebo.

An intent-to-treat analysis was completed on 43 analyzable patients. The mean change in BDD-YBOCS score from baseline to study end was -12.6 for the fluoxetine group (n = 25) and -9.22 for the placebo group (n = 18). These differences did not reach statistical significance, but there was a moderate effect size (d = 0.29).

Importantly, Dr Hollander said, fluoxetine was well tolerated. "We didn't see any suicidal thoughts or behaviors with fluoxetine in this pediatric population with BDD."

A key limitation of the study is the small sample size. "It is important that treatments for BDD continue to be studied, as symptoms can be chronic and severely disabling," the investigators note in their APA 2015 poster.

"Furthermore, pediatric-onset BDD appears to interfere with the developmental tasks of childhood/adolescence, to have a more malignant course of illness than adult-onset BDD, and, when untreated, to persist and cause substantial morbidity throughout the lifespan," they point out.

Strong Rationale

"This is an experienced and expert research team who conducted a preliminary study on a very important topic," Scott L. Rauch, MD, president and psychiatrist-in-chief, McLean Hospital, Belmont, Massachusetts, who was not involved in the study, told Medscape Medical News.

"As they indicate, though BDD often has its onset in youth, there are apparently no prior placebo-controlled studies of SSRI treatment in adolescents. SSRIs can be an effective treatment in adults, and SSRIs are used in adolescents for other indications. So this is a study with strong rationale," said Dr Rauch.

"Though on average, subjects who received the SSRI treatment had greater reduction in symptoms than those who received placebo, this difference was modest in magnitude and did not reach statistical significance. This study could pave the way for a larger, more definitive study. But it would be premature to conclude that SSRIs are or are not efficacious in treating BDD in adolescents," Dr Rauch added.

David Veale, MD, from the Institute of Psychiatry, King's College London, United Kingdom, thinks the findings are "disappointing and somewhat surprising," because in adults with BDD, there is a "modest but significant" benefit from fluoxetine. "It may be that pediatric BDD is less responsive to fluoxetine, perhaps similar to depression, although it very much depends on who is recruited to such studies," noted Dr Veale, who commented on the study for Medscape Medical News.

Bruce R. Clark, PhD, of South London and Maudsley NHS Foundation Trust, in London, told Medscape Medical News that this is an "interesting study but, sadly, with a small sample size and therefore not able to show a robust effect size."

Dr Clark, who also was not involved in the study, noted that the diagnosis of BDD is often "completely missed and then not well tackled when it is found. I think there is new and increased interest in this field. I'm sure the disorder will gain more salience in child practice over time. That is, in part, why I think this study from some of the best North American centers for BDD is useful, as it adds to the overall knowledge base."

Currently, the practice of treating BDD in children and young people "typically follows what is done in adult practice. This would include cognitive-behavior therapy and high-dose SSRI medication strategies (as examined in this study). Evidence for both is lacking, although emerging," Dr Clark said.

The study was funded by grants from the Orphan Products Division of the US Food and Drug Administration and by the National Institute of Mental Health. The authors have disclosed no relevant financial relationships.

American Psychiatric Association (APA) 2015 Annual Meeting. Abstract P06-076. Presented May 18, 2015.

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