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Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment
Official Title  Biological Predictors of Response to Antidepressants
Brief Summary

This study will use pre-treatment positron emission topography and functional magnetic resonance imaging scans of the brain to predict the most effective antidepressant treatment for people with major depressive disorder.

Detailed Description

Major depressive disorder (MDD) is characterized by a combination of symptoms that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Studies have shown that as little as 50% to 60% of individuals with MDD may respond to the first antidepressant medication prescribed. Currently psychiatrists lack tools that allow them to select the treatment plan that is most likely to benefit a particular individual. Some of the chemical abnormalities in the brains of people with MDD are detectable on positron emission topography (PET) scans. There are distinct differences in the PET scans of people with MDD who respond to treatment with a selective serotonin reuptake inhibitor (SSRI), people with MDD who do not respond to SSRI treatment, and people who do not have MDD. This study will use pretreatment PET and functional magnetic resonance imaging (fMRI) scans of the brain to predict which antidepressants will be most effective in people with MDD. This may help to reduce the trial and error currently associated with antidepressant treatment.

Participants in this study will undergo one PET scan and one fMRI scan. Within 3 days of the scan, all participants will begin taking escitalopram, an SSRI, at a daily dose of 10 mg. After 4 weeks, participants who have responded to treatment will continue for an additional 4 weeks at a 10-mg daily dose. Participants who do not respond to the medication at the end of 4 weeks will begin taking 20 mg of escitalopram per day. After 8 weeks, participants for whom escitalopram does not succeed in relieving MDD symptoms will take desipramine, a norepinephrine reuptake inhibitor (NRI), for an additional 8 weeks. If desipramine is ineffective, participants may receive any treatment agreed upon by their treating physicians. Study visits will occur weekly for the first 4 weeks and then every other week for the remainder of the study. At visits, participants will meet with their psychiatrists to discuss how they have been feeling since the last visit, review medication side effects, and complete depression rating questionnaires. Outpatient participants will receive a total of 5 months of treatment for depression, and inpatient participants will receive treatment until they have achieved remission.

Study Phase
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure  Remission of depressive symptoms [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Improvement in scores on the Hamilton Depression Rating Scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Condition  Depression
Intervention  Drug: Escitalopram
Drug: Desipramine
MEDLINE PMIDs
Links Click here for Columbia University and NYSPI's Department of Neuroscience Web site This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  September 2006
Completion Date September 2011
Eligibility Criteria 

Inclusion Criteria:

  • Diagnosis of major depressive disorder
  • Currently depressed

Exclusion Criteria:

  • Current abuse of or dependence on alcohol or another substance
  • Pregnant, breastfeeding, or planning to become pregnant during the study
  • Any unstable medical conditions
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Katrina Bruckschwaiger, BS     212-543-0483     depression-study@columbia.edu    
Contact: Orlando Diaz, MA     212-543-6503     od2003@columbia.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00456014
Organization ID R01 MH74813
Secondary IDs †† DATR A3-NSS
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Ramin V. Parsey, MD, PhD     Columbia University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date April 2008
First Received Date  April 2, 2007
Last Updated Date April 14, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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