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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jay Amsterdam, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00641108
First received: March 19, 2008
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Depression
 Drug: ADAM SPECT plus Cognitive Therapy
Drug: ADAM SPECT plus No Therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Psychotherapy on Brain Serotonin Activity

Resource links provided by NLM:

MedlinePlus related topics: Depression
Drug Information available for: Serotonin
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change in serotonin transporter availability [ Time Frame: Measured at Weeks 0 and 12 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADAM SPECT
Participants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy.
 Drug: ADAM SPECT plus Cognitive Therapy
Active Comparator: Control
Healthy subjects without depression will undergo ADAM SPECT scans.
 Drug: ADAM SPECT plus No Therapy

Detailed Description:

Depression is a serious illness that affects almost 19 million adults in the United States each year. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. A person's depression can be attributed to a variety of causes, including biological and genetic factors, environmental influences, or developmental experiences. Among biological factors, a recently researched possible cause is the altered activity of specialized areas on brain nerve cells called serotonin receptors, which have been found to be at reduced levels in people with depression. The hormone serotonin is known to naturally influence mood, making depression treatments that aim to increase levels of serotonin important. Treatment for depression with cognitive behavioral therapy (CBT), which teaches ways to modify thoughts and behaviors that contribute to depression, may help in raising brain serotonin levels and in improving depressive symptoms. This study will examine changes in brain serotonin activity using single photon emission computed tomography (SPECT) imaging in people with depression before and after they receive CBT. The study will also use SPECT imaging to compare brain serotonin activity of non-depressed healthy participants with that of depressed participants.

Participation in this study will last between 12 and 14 weeks. All participants will first undergo an initial evaluation that will include questions about medical history, a physical exam, a blood draw, a urine test, and an electrocardiogram (ECG). Participants will then undergo an ADAM (a selective radioligand for SPECT imaging) SPECT scan. During the ADAM SPECT scan visit, participants will undergo an injection of the ADAM, an ECG, blood pressure monitoring, and a 60-minute SPECT scan. If necessary, participants may also be asked to have a magnetic resonance imaging (MRI) brain scan after completing the SPECT scan.

Depressed participants will then attend at least once weekly CBT sessions for 12 weeks. During the 45-minute sessions, participants will meet with a therapist to learn ways to adjust thoughts and behaviors that may be adding to their depression. After completing the 12 weeks of CBT, all participants will be re-evaluated by a study doctor and, if still in good health, will undergo a repeat ADAM SPECT scan.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641108

Locations
United States, Pennsylvania
Depression Research Unit - University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Robert J. DeRubeis, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Jay Amsterdam, Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00641108     History of Changes
Other Study ID Numbers: R34 MH077580, R34MH077580, DATR A5-ETMA
Study First Received: March 19, 2008
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
SPECT Brain Imaging
Cognitive Therapy
Serotonin Transporter Binding
Predictive Biomarker

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin
 Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013