Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

We propose to conduct the first pharmacotherapy relapse prevention study in body dysmorphic
disorder (BDD). BDD, an often-delusional preoccupation with a nonexistent or slight defect in
appearance, is a distressing, impairing, and common body image disorder. It is associated
with high rates of functional impairment and markedly poor quality of life. It appears that
serotonin reuptake inhibitors (SRIs) are often--and selectively--efficacious for BDD and that
many BDD patients receive SRIs. It also appears that most patients discontinue an efficacious
SRI at some point, as the alternative is life-long treatment. However, no relapse prevention
studies have been done. Such a study is important from a clinical and public health
perspective, because BDD appears to often be chronic and require long-term treatment. It is
therefore critically important to investigate the risk of relapse with SRI discontinuation,
and whether continuation SRI treatment decreases relapse risk.

Subjects will be enrolled and first treated openly for 14 weeks with escitalopram; 58
escitalopram responders will then be randomized to double-blind continuation treatment with
escitalopram or placebo for 6 additional months. Our primary aim is to compare time to
relapse and relapse rates in responders to acute escitalopram who are then randomized to
placebo versus continuation treatment with escitalopram. Secondary/exploratory aims will
explore 1) Whether subjects who receive continuation escitalopram perform better on secondary
outcome measures (e.g., quality of life) than those on placebo; 2) Change in symptoms with
continuation of escitalopram during the continuation phase; and 3) Acute treatment response.

In summary, this study will be the first relapse prevention study in BDD and the first study
of continuation pharmacotherapy in BDD. It will provide critically important information on
relapse with continuation versus discontinuation of an SRI, whether continuation treatment
protects against relapse, and change in symptoms with continuation treatment. This study will
yield unique and clinically important data, and will fill gaps in knowledge about this
common, severe, and understudied illness.

Inclusion Criteria:

- Outpatient men and women age 18 and older

- Diagnosis of BDD within 6 months of study start date based on the Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV)

- Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale

- Lives within driving distance of Boston, MA or Providence, RI

Exclusion Criteria:

- Suicidal or homicidal tendencies

- Alcohol/drug abuse or dependence within 3 months of study entry