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Phase 3 N=66 Randomized Other

Effects of Antidepressant Therapy on Brain Dopamine Transporter Activity in People With Major Depression

Depression

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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