Effects of Cognitive Behavioral Therapy on Brain Serotonin Activity in People With Depression

Completed · Phase 2/Phase 3

Conditions studied: Depression

In brief

This study will examine changes in brain serotonin activity in people with depression before and after they receive cognitive behavioral therapy.

Key facts

Study ID

NCT00641108

Run by

University of Pennsylvania

People needed

30

Starts

2008-01-01

Expected to finish

2011-12-01

Last updated by the study team

2020-04-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Depression Research Unit - University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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