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Clinical Trials/NCT00655057
NCT00655057
Completed
Phase 2

SPECT Brain Imaging as a Bio-Marker of Major Depression

University of Pennsylvania1 site in 1 country66 target enrollmentOctober 2005

Overview

Phase
Phase 2
Intervention
TRODAT-1 single photon emission computed tomographic (SPECT) imaging
Conditions
Depression
Sponsor
University of Pennsylvania
Enrollment
66
Locations
1
Primary Endpoint
Change in Dopamine Transporter Binding
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study will examine changes in brain dopamine transporter activity before and after antidepressant therapy.

Detailed Description

Depression is a serious psychiatric disorder that affects about 10% of the adult population in the United States in a given year. Common symptoms of depression include a persistent down mood and disinterest in previously enjoyed activities, often causing strain on work, social, and family life. A person's depression can be attributed to a variety of causes, including physiological and sociological factors. Among physiological factors, dopamine (DA), a chemical associated with feelings of happiness and pleasure, may play a key role in the onset of depression and may also be involved in the beneficial effect of antidepressant medication. Recent studies have found that people with depression have increased DA transporter (DAT) levels in a specific region of the inner brain called the striatum. The increased DAT levels might reflect alterations in central DA function. Treatment for depression with selective serotonin reuptake inhibitor (SSRI) antidepressant therapy may help in returning DAT levels to normal and in improving depressive symptoms. Using single photon emission computed tomography (SPECT) imaging, this study will examine changes in brain DAT activity in people with depression before and after they receive SSRI antidepressant therapy or cognitive behavioral therapy (CBT). Participation in this study will last about 14 weeks and will involve participants who are healthy and depressed. All participants will first undergo baseline assessments that will include a medical history, questions about current and past health, a physical exam, a blood draw, a urine sampling, and an electrocardiogram (ECG). After completing the baseline assessments, participants will undergo a TRODAT-1 SPECT scan, which will involve an injection of TRODAT-1 (a radioactive agent to measure DA) and, after a 3-hour break, a 75-minute SPECT scan. If necessary, participants may also be asked to have a magnetic resonance imaging (MRI) brain scan after completing the SPECT scan. Participants with depression will then be assigned randomly to undergo 12 weeks of treatment with either the antidepressant medication s-citalopram or CBT. Participants assigned to take s-citalopram will return for study visits weekly for 2 weeks, every other week for 6 weeks, and then monthly for 4 weeks. During study visits, participants will receive their medication, answer questions about depression and medication side effects, and occasionally fill out general health questionnaires. Participants receiving CBT will attend twice weekly sessions for 2 weeks and then once weekly sessions for 10 weeks. Sessions will focus on modifying thoughts and behaviors that may contribute to depression. After 12 weeks, all participants will be re-evaluated by a study doctor and, if still in good health, will undergo a repeat TRODAT-1 SPECT scan.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
December 2009
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

1

Healthy participants will undergo TRODAT-1 SPECT imaging.

Intervention: TRODAT-1 single photon emission computed tomographic (SPECT) imaging

2

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.

Intervention: S-citalopram

2

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with s-citalopram.

Intervention: TRODAT-1 single photon emission computed tomographic (SPECT) imaging

3

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.

Intervention: Cognitive behavioral therapy (CBT)

3

Participants with depression will undergo TRODAT-1 SPECT imaging and treatment with cognitive behavioral therapy.

Intervention: TRODAT-1 single photon emission computed tomographic (SPECT) imaging

Outcomes

Primary Outcomes

Change in Dopamine Transporter Binding

Time Frame: Measured at Weeks 0 and 12

Study Sites (1)

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