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Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression (ssrifMRI)
This study is currently recruiting participants.
Verified by University of Pittsburgh, November 2008
Sponsors and Collaborators: University of Pittsburgh
Pittsburgh Foundation
National Institute of Mental Health (NIMH)
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00787501
  Purpose

Our goals are 1) to use functional magnetic resonance imaging (fMRI) to predict which depressed individuals will respond to different validated treatments for unipolar depression including Cognitive Therapy (CT) and antidepressant medications (selective serotonin reuptake inhibitors; SSRIs) and 2) to understand whether CT and SSRIs affect similar aspects of brain function underlying cognition and emotion. Thus, we will examine depressed adults ages 18-55 using fMRI during cognitive and emotional information processing tasks, before and after treatment with an SSRI (n=25) or CT (n=40). We hypothesize that: 1) Recovery will occur in treatment with an SSRI primarily for individuals with increased reactivity in limbic brain regions associated with emotion generation and prefrontal regions associated with regulation,. 2) Recovery with CT will occur for patients with increased activity in brain regions associated with emotion generation but decreased activity in prefrontal regions associated with emotion regulation. 3) Recovery with an SSRI will yield similar changes in brain function to CT in brain regions associated with emotion generation but less change in brain regions responsible for emotion regulation such as the prefrontal cortex. Findings from this study may have a profound impact on reducing the burden of clinical depression by providing evidenced-based diagnostic and treatment guidelines.


Condition Intervention
Major Depressive Disorder
Drug: SSRI
Behavioral: CBT

MedlinePlus related topics: Antidepressants Depression
Drug Information available for: Sertraline hydrochloride Sertraline Fluoxetine Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Serotonin Fluoxetine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Treatment outcome will be assessed on a variety of dimensions including change in symptoms, self-reported rumination, behavioral performance on cognitive tasks, and physiological reactivity to emotional information processing tasks. [ Time Frame: 14-16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SSRIs: Active Comparator
Selective Serotonin Reuptake Inhibitors
Drug: SSRI
SSRI: 25 patients will receive 14 weeks of an FDA approved selective serotonin reuptake inhibitor (SSRI), administered under the supervision of a staff psychiatrist. After an initial 30-45 minute session patients will be seen for 15-30 minute sessions for 16-20 sessions over 14 weeks. Medication will begin with 10mg escitalopram daily (or its equivalent), increased to 30 mg/day (or its equivalent) by week 6 if pt has not achieved a minimum level of response (i.e., CGI < 2) and tolerability is adequate. Nonresponse at week 10 (CGI < 2) will be cause for medication switch or augmentation.
CBT: Active Comparator
Cognitive Behavior Therapy
Behavioral: CBT
Cognitive Behavior Therapy: 40 patients will receive 16- 20 60 minute sessions of procedurally determined Cognitive Therapy (Beck, 1979) over 14 weeks. Patients will begin with 2 sessions per week which may be reduced to once per week in the latter part of the study period if the patient is responding to the therapy. Cognitive Therapy is designed to teach skills that help to reduce depressive severity. Each session will be videotaped and will include homework to be completed and brought to the following session.

Detailed Description:

Same as above.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet DSM-IV criteria for major depressive disorder (one or more lifetime episodes, separated by at least two months of a return to normal functioning, in a current episode).
  2. Male or female outpatients between the ages of 18 and 55 at time of enrollment.
  3. Females only must be surgically sterile, post-menopausal for at least one year, or not pregnant and using a method of birth control that is acceptable to the investigator.
  4. Have a total score of 14 or more on the first 17-items of the HRSD at both the initial and secondary interviews.
  5. Be in reasonably good health. Patients with hypothyroidism, diabetes, high blood pressure, chronic respiratory, or other medical conditions may be considered candidates for study enrollment at the discretion of the investigator if their conditions are stable, they have been receiving standard therapies for the treatment of the condition, the prescribed dose and regiment of medication has been stable for at least 3 months, and all appropriate clinical and lab parameters are within normal limits for the condition that are clinically acceptable to the investigator
  6. Be free of prescription psychotropic medications for two weeks (four weeks for fluoxetine) before study entry.
  7. Provide written informed consent

Exclusion Criteria:

  1. Being unable to complete questionnaires written in English, representing an active suicide risk (see below), active alcohol or drug dependence, having any eye problems or difficulties in corrected vision, having a North American Adult Reading Test (NAART) equivalent FSIQ < 85.
  2. Pregnant women and those planning to become pregnant during the first 11 months after intake will also be excluded from the study. Pregnancy will be determined by self-report at the interview and by a pregnancy test at the time of the MRI scan. There will be no cost to the participant for the pregnancy test.
  3. People who have metallic foreign objects in their body, such as aneurysm clips or pacemakers, as well as individuals prone to panicking in enclosed spaces will be excluded from the study. Subjects with a questionable history of metallic fragments will also be excluded.
  4. Participants who are taking psychotropic medications, particularly antidepressant medications within two weeks of study entry (4 weeks for fluoxetine) will be excluded.
  5. Participants will not be excluded on the basis of herbs, supplements, and other prescription or over the counter drugs other than those noted. HIV serostatus will not be evaluated for the research study.
  6. At the initial screening visit, if girth seems to present a potential issue for the MRI, than width of participant will be assessed using a hula-hoop that is approximately the same diameter as the MR scanner. If subject exceeds the width of the hula-hoop, then they will be excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787501

Contacts
Contact: Susan R Berman 412-246-6111 bermansr@upmc.edu
Contact: Agnes E Haggerty 412-383-5443 haggertyae3@upmc.edu

Locations
United States, Pennsylvania
Mood Disorders Treatment and Research Program - UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Susan R Berman     412-246-6111     bermansr@upmc.edu    
Contact: Agnes E Haggerty     412-383-5443     haggertyae3@upmc.edu    
Sub-Investigator: Edward S Friedman            
Sub-Investigator: Robert H Howland, M.D.            
Sub-Investigator: Timothy Denko, M.D.            
Sub-Investigator: Duane Spiker, M.D.            
Sub-Investigator: Michael Thase, M.D.            
Sponsors and Collaborators
University of Pittsburgh
Pittsburgh Foundation
Investigators
Principal Investigator: Greg J Siegle, PhD University of Pittsburgh
  More Information

Dr. Siegle's PICAN lab website  This link exits the ClinicalTrials.gov site
MDTRP website  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: University of Pittsburgh School of Medicine ( Greg Siegle, PhD/Principal Investigator )
Study ID Numbers: PRO07100326, M2007-0114
Study First Received: November 5, 2008
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00787501  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
MDD
Depression
SSRIs
CBT
Cognitive Behavior Therapy
Cognitive Therapy
antidepressant medications

Study placed in the following topic categories:
Fluoxetine
Depression
Mental Disorders
Mood Disorders
Sertraline
Depressive Disorder, Major
Dexetimide
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009