Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT00655057
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00655057
Study Brief:
Protocol Section:
NCT00655057