Status:
COMPLETED
Effects of Cognitive Behavioral Therapy on Brain Serotonin Activity in People With 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 serotonin activity in people with depression before and after they receive cognitive behavioral therapy.
Detailed Description
Depression is a serious illness that affects almost 19 million adults in the United States each year. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irre...
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of major depressive disorder (MDD)
- Drug naive from prior psychotropic medication for more than 6 months before study entry
- Hamilton-Depression (HAM-D) 17 score greater than or equal to 16
- Woman of childbearing age with a negative pregnancy test within 48 hours of scanning
Exclusion
- DSM-IV Axis I diagnosis other than MDD
- Use of psychotropic medication within 6 months of study entry
- History of bipolar disorder
- Current alcohol or drug abuse/dependence within 6 months of 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 nursing
- 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 more than 24 hours in duration)
- 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 major depressive episode
- History of normal pressure hydrocephalus
- History of cancer metastatic to the central nervous system
- History of Parkinson's or other basal ganglia disease
- History of Guillain-Barré syndrome (chronic or relapsing polyneuropathy)
- Inability to undergo an MRI scan
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00641108
Start Date
January 1 2008
End Date
December 1 2011
Last Update
April 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Depression Research Unit - University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3309