Escitalopram Neuroimaging Supplement

Completed

• Conditions: Body Dysmorphic Disorder

• Registration Number: NCT01398865
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this study is to find out more about the brain's response to selective serotonin reuptake inhibitor (SSRIs) treatment in people with body dysmorphic disorder (BDD). The investigators will use positron emission tomography (PET) and Magnetic Resonance Imaging (MRI) scans to look at brain activity in people with BDD before and after treatment with an SSRI. The investigators hope that what is learned will allow prediction of whether someone will improve with SSRI treatment.

Detailed Description

The investigators have chosen to focus on five regions of interest, namely ACC, OFC, caudate, amygdala and hippocampus. These are brain regions that have been previously associated with obsessive-compulsive, affective, and psychotic phenomena. The investigators will test for correlations between pre-treatment FDG brain images and subsequent SSRI treatment outcome to identify potential predictors of treatment response. Finally, the investigators will compare pre-treatment and post-treatment PET FDG studies as well as MRI studies in BDD subjects to examine changes in these brain regions following treatment. The goals of the proposed research are to use FDG-PET and MRI to identify predictors of treatment response to SSRIs in BDD and to determine changes in rCMRglu in BDD subjects following treatment with SSRIs.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2011-07-15
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-21
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• male or female.
• from 18-64 years of age.
• right-handed, by virtue of assessment with the Edinburgh Handedness Inventory
• capacity to render informed consent.
• already enrolled in clinical study NCT00149799.
• must be an outpatient with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of BDD, as defined by DSM-IV criteria and by a BDD Yale-Brown Obsessive-Compulsive Scale Score greater than or equal to 24.

Exclusion Criteria

• with serious medical illness or instability for which hospitalization may be likely within four months of entry into the study, or current renal insufficiency or diabetes.
• any pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded. Pregnancy status will be determined by administration of a blood beta-HCG test prior to each PET scan.
• with recent or anticipated radiation exposure, which, combined with the exposure in the present study, will exceed allowable annual limits for the subject
• with a history of hypersensitivity to any component of FDG
• with specific comorbid psychiatric diagnoses (alcohol abuse or dependence within the past 3 months, bipolar disorder, psychosis, organic mental disorder, development disorder, borderline personality disorder, body image concerns accounted for primarily by an eating disorder or weight concerns). If subjects have another comorbid diagnosis, the BDD must be the primary concern.
• MRI- incompatibilities (for example, metal implants, pacemakers)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BDD-YBOCS	9 months	We will test for correlations between pre-treatment FDG brain images and subsequent SSRI treatment outcome to identify potential predictors of treatment response. Statistical parametric maps will be used to assess the relationship between rCMRglu and subsequent clinical response (expressed as percent change in BDD-YBOCS).

Secondary Outcome Measures

Name	Time	Method
PET FDG and MRI studies	9 months	We will compare pre-treatment and post-treatment PET FDG studies as well as MRI studies in BDD subjects to examine changes in these brain regions following treatment.

Trial Locations

Locations (1)

OCD & Related Disorders Clinic; 🇺🇸 Boston, Massachusetts, United States