Phase 3
N=66
Effects of Antidepressant Therapy on Brain Dopamine Transporter Activity in People With Major Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00655057 ↗Enrolled (actual)
66
Serious AEs
—
Results posted
Apr 2020
Primary outcome: Primary: Change in Dopamine Transporter Binding
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- S-citalopram (Drug); Cognitive behavioral therapy (CBT) (Behavioral); TRODAT-1 single photon emission computed tomographic (SPECT) imaging (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Dopamine Transporter Binding |
— | — |
Summary
This study will examine changes in brain dopamine transporter activity before and after antidepressant therapy.
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
Data sourced from ClinicalTrials.gov (NCT00655057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.