Effects of Cognitive Behavioral Therapy on Brain Serotonin Activity in People With Depression - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00641108

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	Procedure: 123I-ADAM SPECT Behavioral: Cognitive behavioral therapy (CBT)	Phase II Phase III

MedlinePlus related topics: Depression

Drug Information available for: Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Dose Comparison, Parallel Assignment
Official Title:	Effect of Psychotherapy on Brain Serotonin Activity

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Participants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy.	Procedure: 123I-ADAM SPECT Participants will undergo two ADAM SPECT scans 12 weeks apart. During the ADAM SPECT scan procedure, participants will undergo an injection of the ADAM (180 MBq), an ECG, blood pressure monitoring, and a 60-minute SPECT scan. Behavioral: Cognitive behavioral therapy (CBT) CBT will include at least once weekly 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.
II: Active Comparator Healthy participants without depression will undergo ADAM SPECT scans only.	Procedure: 123I-ADAM SPECT Participants will undergo two ADAM SPECT scans 12 weeks apart. During the ADAM SPECT scan procedure, participants will undergo an injection of the ADAM (180 MBq), an ECG, blood pressure monitoring, and a 60-minute SPECT scan.

Arms

Assigned Interventions

I: Experimental

Participants with depression will undergo ADAM SPECT scans and cognitive behavioral therapy.

Procedure: 123I-ADAM SPECT

Participants will undergo two ADAM SPECT scans 12 weeks apart. During the ADAM SPECT scan procedure, participants will undergo an injection of the ADAM (180 MBq), an ECG, blood pressure monitoring, and a 60-minute SPECT scan.

Behavioral: Cognitive behavioral therapy (CBT)

CBT will include at least once weekly 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.

II: Active Comparator

Healthy participants without depression will undergo ADAM SPECT scans only.

Procedure: 123I-ADAM SPECT

Participants will undergo two ADAM SPECT scans 12 weeks apart. During the ADAM SPECT scan procedure, participants will undergo an injection of the ADAM (180 MBq), an ECG, blood pressure monitoring, and a 60-minute SPECT scan.

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

Contacts

Contact: Jay D. Amsterdam, MD	215-662-3462	jamsterd@mail.med.upenn.edu
Contact: Maryanne Giampapa, BBA	215-662-2835	mgiampap@mail.med.upenn.edu

Locations

United States, Pennsylvania
Depression Research Unit - University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104-3309
Contact: Jay D. Amsterdam, MD 215-662-3462 jamsterd@mail.med.upenn.edu
Contact: Maryanne Giampapa, MD 215-662-2835 mgiampap@mail.med.upenn.edu
Principal Investigator: Jay D. Amsterdam, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Jay D. Amsterdam, MD

University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania ( Jay D. Amsterdam, MD, Professor )
Study ID Numbers:	R34 MH077580, DATR A5-ETMA
Study First Received:	March 19, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00641108
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Mental Health (NIMH):

SPECT Brain Imaging
Cognitive Therapy
Serotonin Transporter Binding
Predictive Biomarker

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009