Clinical trial NCT00149799: Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
Official title: Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
Somatoform Disorders
Keywords: Body Dysmorphic Disorder
Escitalopram
Lexapro
BDD
Body Image
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Rhode Island Hospital
First posted: 2005-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study's 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)
timeFrame: Phase II: Biweekly for six months after randomization
Secondary outcomes:
measure: Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)
timeFrame: Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14
measure: Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
timeFrame: Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40
measure: Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
timeFrame: Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)
measure: Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
timeFrame: Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Massachusetts General Hospital (MGH)
name: Sabine Wilhelm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital (RIH)
name: Katharine Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fang A, Porth R, Phillips KA, Wilhelm S. Personality as a Predictor of Treatment Response to Escitalopram in Adults With Body Dysmorphic Disorder. J Psychiatr Pract. 2019 Sep;25(5):347-357. doi: 10.1097/PRA.0000000000000415.
citation: Weingarden H, Shaw AM, Phillips KA, Wilhelm S. Shame and Defectiveness Beliefs in Treatment Seeking Patients With Body Dysmorphic Disorder. J Nerv Ment Dis. 2018 Jun;206(6):417-422. doi: 10.1097/NMD.0000000000000808.