Escitalopram Neuroimaging Supplement

Body Dysmorphic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398865
• Other study ID #: 2008P002032
• Status: Completed
• Phase: N/A
• First received: July 15, 2011
• Last updated: March 12, 2015
• Start date: December 2008
• Est. completion date: March 2013

Study information

• Verified date: March 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Dysmorphic Disorder
• Body Dysmorphic Disorders

Intervention

Procedure:
• PET scan and MRI scan
PET: The PET Scan is manufactured by Siemens and the model is the Exact HR+ .rCMRglu data will be gathered over a 30 minute resting period using a Siemens HR+ PET camera (4.5 mm in-plane and axial resolution). The total time for an individual PET session, will thus be one hour and a half (30 minutes for serum pregnancy test and 30 minute uptake period followed by 30 minutes of scanning). MRI: High-resolution scans will be acquired using a Seimens (manufacturer) 1.5T Avonta system at MGH, to be coregistered with subsequently acquired PET images, and used for A) delineation of regions of interest (ROIs), and B) facilitation of optimal transformation to MNI space.

Locations

Country	Name	City	State
United States	OCD & Related Disorders Clinic	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDD-YBOCS	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).	9 months	No
Secondary	PET FDG and MRI studies	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.	9 months	No

External Links

•   Mass General Hospital OCD/BDD clinic website