Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram

This study has been completed.
Information provided by (Responsible Party):
Darin Dougherty, Massachusetts General Hospital Identifier:
First received: July 10, 2012
Last updated: September 15, 2014
Last verified: September 2014

Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET). The following hypothesis will be tested: Antidepressant response or remission in depressed BPD patients will be associated with changes in cortical (prefrontal, parietal, premotor) and paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior cingulate, and anterior insula) regions, consistent with SRI antidepressant response in unipolar depressed patients.

Bipolar Depression

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • rCMRglu [ Time Frame: pre and post-treatment ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Bipolar Depression


Inclusion Criteria:

  • Current age 18-64 years; DSM-IV diagnosis of BPD, type-I, or type-II; Enrolled in the Citalopram Study at Tufts Medical Center

Exclusion Criteria:

  • Current pregnancy, or inability to utilize contraception, The presence of any metallic implants, History of claustrophobia
  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 identifier: NCT01639482

United States, Massachusetts
Massachusetts General Hospital - East
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Darin Dougherty, Director, Division of Neurotherapeutics, Massachusetts General Hospital Identifier: NCT01639482     History of Changes
Other Study ID Numbers: 2009P002712
Study First Received: July 10, 2012
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Behavioral Symptoms processed this record on February 27, 2015