Escitalopram Neuroimaging Supplement

NCT01398865 | Completed

• 1 other identifier: 2008P002032
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Dysmorphic Disorder

Keywords

BDD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• PET FDG and MRI studies

  9 months

Interventions

PET scan and MRI scan PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be 24 subjects with BDD newly enrolled, but not yet treated, in a multi-site (MGH and Rhode Island Hospital) clinical study of escitalopram for BDD (NCT00149799/R01MH072854), Dr. Wilhelm, PI). All BDD subjects will be drawn from this clinical study, in order to best ensure that they have all received a comparable regimen of SSRI treatment. BDD subjects will have been recruited via the BDD Clinic at Massachusetts General Hospital (MGH)/Harvard Medical School and Rhode Island Hospital/Brown Medical School.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

OCD & Related Disorders Clinic

Boston, Massachusetts, 02114, United States

Location

Related Links

• Mass General Hospital OCD/BDD clinic website

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sabine Wilhelm, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 21, 2011
• Study Start: December 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 13, 2015

Record last verified: 2015-03

Locations

US (1)