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Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01639482
Collaborator
(none)
60
Enrollment
1
Location
44
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram
    Study Start Date :
    Apr 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Citalopram

    Patients with bipolar disorder
    Placebo

    Patients with bipolar disorder

    Outcome Measures

    Primary Outcome Measures

    1. rCMRglu [pre and post-treatment]

      regional glucose metabolism

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital - East Charlestown Massachusetts United States 02129

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Darin D Dougherty, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Darin Dougherty, Director, Division of Neurotherapeutics, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT01639482
    Other Study ID Numbers:
    • 2009P002712
    First Posted:
    Jul 12, 2012
    Last Update Posted:
    Mar 7, 2019
    Last Verified:
    Mar 1, 2019
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Bipolar Disorder

    Study Results

    No Results Posted as of Mar 7, 2019