Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Darin Dougherty, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01639482
First received: July 10, 2012
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition
Bipolar Depression

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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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

Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Citalopram
Placebo

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01639482

Locations
United States, Massachusetts
Massachusetts General Hospital - East Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Andrew K Corse, BA    617-643-5129    acorse@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Darin Dougherty, Director, Division of Neurotherapeutics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01639482     History of Changes
Other Study ID Numbers: 2009P002712
Study First Received: July 10, 2012
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014