Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

• Functioning and life satisfaction (as measured by the LIFE) [ Time Frame: Measured four times throughout study (Screening, EW14, EW28 and EW40) ] [ Designated as safety issue: No ]
• Depressive symptoms (as measured by the BDI-II) [ Time Frame: Measured biweekly for six months after randomization ] [ Designated as safety issue: No ]
• Anxiety symptoms (as measured by the SIGH-D) [ Time Frame: Measured at every study visit for 40 weeks ] [ Designated as safety issue: No ]
• Delusionality of BDD symptoms (as measured by the BABS) [ Time Frame: Measured at every study visit for 40 weeks ] [ Designated as safety issue: No ]

• At each study visit:
• Functioning and life satisfaction
• Depressive symptoms
• Anxiety symptoms

This study will assess the relapse-prevention rate of escitalopram (Lexapro) in the treatment of body dysmorphic disorder.

Body Dysmorphic Disorder (BDD) is a mental disorder in which a person is preoccupied by a very slight physical anomaly or an imagined defect in his or her appearance. It is associated with Obsessive Compulsive Disorder (OCD). Treatment of BDD usually reduces symptoms of the disorder, but some people's symptoms regress only for a short time and then reappear. Drugs that will reduce the risk of BDD-relapse are needed. Escitalopram, also known as Lexapro, is a serotonin reuptake inhibitor (SRI). It is an oral drug used to treat depression and general anxiety disorder. Its ability to prevent relapse of BDD has not yet been studied. This study will evaluate the relapse-prevention rate of escitalopram for the treatment of BDD.

The study will start with an open-label phase, during which all participants will receive escitalopram for 14 weeks. Study visits will occur once weekly for the first month and once every other week for the remainder of the 14 weeks. At the end of this initial phase, those who show improvement will continue into a double-blind phase. The remaining participants will be randomly assigned to receive either escitalopram or placebo for an additional 6 months. Study visits will occur once every other week, with an additional visit at Week 15. Participants' improvement or return of BDD-related symptoms will be assessed. Throughout the 6 months, any participant showing relapse will be referred to alternate treatment.

• Anxiety Disorders
• Somatoform Disorders

• Drug: Escitalopram
  All participants will receive escitalopram for 14 weeks. The dosages will be 10 mg for 2 weeks, 20 mg for 2 weeks, and 30 mg for 10 weeks.
  Other Name: Lexapro
• Drug: Placebo
  After the initial 14 weeks of escitalopram treatment, participants then randomly assigned to placebo will take placebo capsules for an additional 6 months.
• Drug: Escitalopram extension
  At the end of the initial 14-week phase, participants then randomly assigned to escitalopram will receive treatment with escitalopram for an additional 6 months.

• Experimental: Escitalopram
  Participants taking Escitalopram only for both Phase I and Phase II of the trial
  Interventions:

  • Drug: Escitalopram
  • Drug: Escitalopram extension
• Placebo Comparator: Placebo
  Participants taking Escitalopram for Phase I of the study (Weeks 1-14) followed by a placebo for Phase II of the study (Weeks 16-40)
  Interventions:

  • Drug: Escitalopram
  • Drug: Placebo

Inclusion Criteria:

• Outpatient men and women age 18 and older
• DSM-IV diagnosis of BDD within 6 months of study start date
• 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

• National Institute of Mental Health (NIMH)
• Rhode Island Hospital