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Phase 3 Completed N=30 Other

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

Source: ClinicalTrials.gov NCT00641108 ↗
Enrolled (actual)
30
Serious AEs
Results posted
Apr 2020
Primary outcomePrimary: Change in Serotonin Transporter Availability
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Serotonin Transporter Availability

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. Informational only — not medical advice.

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