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Escitalopram Neuroimaging Supplement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01398865
First received: July 15, 2011
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Body Dysmorphic Disorder
Procedure: PET scan and MRI scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cerebral Metabolic Correlates of Treatment Response to Escitalopram in Body Dysmorphic Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • BDD-YBOCS [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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:
  • PET FDG and MRI studies [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 23
Study Start Date: December 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398865

Locations
United States, Massachusetts
OCD & Related Disorders Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01398865     History of Changes
Other Study ID Numbers: 2008P002032
Study First Received: July 15, 2011
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
BDD

Additional relevant MeSH terms:
Body Dysmorphic Disorders
Disease
Mental Disorders
Pathologic Processes
Somatoform Disorders

ClinicalTrials.gov processed this record on November 27, 2014