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Clinical Trials/NCT01398865
NCT01398865
Completed
Not Applicable

Cerebral Metabolic Correlates of Treatment Response to Escitalopram in Body Dysmorphic Disorder

Massachusetts General Hospital1 site in 1 country23 target enrollmentDecember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Body Dysmorphic Disorder
Sponsor
Massachusetts General Hospital
Enrollment
23
Locations
1
Primary Endpoint
BDD-YBOCS
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
March 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sabine Wilhelm

PhD

Massachusetts General Hospital

Eligibility Criteria

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 NCT
  • 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)

Outcomes

Primary Outcomes

BDD-YBOCS

Time Frame: 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 Outcomes

  • PET FDG and MRI studies(9 months)

Study Sites (1)

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