Phase 3
N=30
Effects of Cognitive Behavioral Therapy on Brain Serotonin Activity in People With Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00641108 ↗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
| Outcome | Result | p-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
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.