Status:
COMPLETED
Effects of Antidepressant Therapy on Brain Dopamine Transporter Activity in People With Major Depression
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This study will examine changes in brain dopamine transporter activity before and after antidepressant therapy.
Detailed Description
Depression is a serious psychiatric disorder that affects about 10% of the adult population in the United States in a given year. Common symptoms of depression include a persistent down mood and disin...
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of major depressive episode (MDE) or major depressive disorder (MDD)
- Drug free of psychotropic medication for more than 6 months before study entry
- 17-item Hamilton Depression Scale (HAM-D17) score of greater than 16
- Woman of childbearing age with a negative pregnancy test within 48 hours of study entry
- Absence of DSM-IV Axis I diagnosis as determined by Structured Clinical Interview for DSM Disorders (SCID)
Exclusion
- DSM-IV Axis I diagnosis other than MDE
- History of mania
- Current alcohol or drug abuse, or alcohol or drug dependence within 6 months before study entry
- History of sensitivity or intolerance to s-citalopram
- Medical contraindication to the use of s-citalopram
- Unstable medical condition (e.g., angina pectoris, untreated hypertension)
- Pregnant or breastfeeding
- Woman of childbearing potential not using a medically acceptable form of birth control
- Actively suicidal or requiring hospitalization
- Requiring additional psychotropic drug therapy
- History of transient ischemic attacks
- History of cerebral infarction (including lacunar infarct with symptoms that last more than 24 hours)
- History of Binswanger's disease (or a history of hypertensive encephalopathy)
- History of intracranial hemorrhage
- History of head trauma with loss of consciousness
- History of encephalitis
- History of extended exposure to known neurotoxin (e.g., cyanide, carbon monoxide)
- Uncontrolled metabolic disorder (e.g., thyroid disease, diabetes mellitus)
- History of cognitive impairment other than MDE
- History of normal pressure hydrocephalus
- History of cancer metastatic to the central nervous system
- History of Parkinson's disease or other basal ganglia disease
- History of Guillain-Barre syndrome (chronic or relapsing polyneuropathy)
- Inability to undergo an MRI scan
- History of DSM-IV Axis I Mood Disorder
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00655057
Start Date
October 1 2005
End Date
December 1 2009
Last Update
April 16 2020
Active Locations (1)
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1
Depression Research Unit - University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104