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Phase 3 N=30 Other

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

Depression

Enrolled (actual)
30
Serious AEs
Results posted
Apr 2020
Primary outcome: Primary: Change in Serotonin Transporter Availability

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
ADAM SPECT plus Cognitive Therapy (Drug); ADAM SPECT plus No Therapy (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pennsylvania
Primary completion
Dec 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Serotonin Transporter Availability

Summary

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

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00641108). 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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