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Completed

NCT Number: NCT01398865

Escitalopram Neuroimaging Supplement

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OCD & Related Disorders Clinic

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. PET FDG and MRI studies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 21, 2011
Registry last updated
Mar 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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