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Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression (ssrifMRI)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SSRI
CBT
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Depression, Selective Serotonin Reuptake Inhibitors, Cognitive Behavior Therapy, Cognitive Therapy, antidepressant medications

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Meet Diagnostic and Statistical Manual-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 Hamilton Rating Scale for Depression 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 Full Scale Intelligence Quotient < 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 Magnetic Resonance Imaging 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 MRI scanner. If subject exceeds the width of the hula-hoop, then they will be excluded from the study.

Sites / Locations

  • Mood Disorders Treatment and Research Program - UPMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SSRIs

CBT

Arm Description

Selective Serotonin Reuptake Inhibitors

Cognitive Behavior Therapy

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2008
Last Updated
January 24, 2019
Sponsor
University of Pittsburgh
Collaborators
The Pittsburgh Foundation, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00787501
Brief Title
Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression
Acronym
ssrifMRI
Official Title
Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
The Pittsburgh Foundation, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Same as above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Depression, Selective Serotonin Reuptake Inhibitors, Cognitive Behavior Therapy, Cognitive Therapy, antidepressant medications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SSRIs
Arm Type
Active Comparator
Arm Description
Selective Serotonin Reuptake Inhibitors
Arm Title
CBT
Arm Type
Active Comparator
Arm Description
Cognitive Behavior Therapy
Intervention Type
Drug
Intervention Name(s)
SSRI
Other Intervention Name(s)
Lexapro, escitalopram, Prozac, fluoxetine, Sertraline, Zoloft
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
CT, Cognitive Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet Diagnostic and Statistical Manual-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). Male or female outpatients between the ages of 18 and 55 at time of enrollment. 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. Have a total score of 14 or more on the first 17-items of the Hamilton Rating Scale for Depression at both the initial and secondary interviews. 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 Be free of prescription psychotropic medications for two weeks (four weeks for fluoxetine) before study entry. Provide written informed consent Exclusion Criteria: 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 Full Scale Intelligence Quotient < 85. 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 Magnetic Resonance Imaging scan. There will be no cost to the participant for the pregnancy test. 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. Participants who are taking psychotropic medications, particularly antidepressant medications within two weeks of study entry (4 weeks for fluoxetine) will be excluded. 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. 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 MRI scanner. If subject exceeds the width of the hula-hoop, then they will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg J Siegle, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mood Disorders Treatment and Research Program - UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16585452
Citation
Siegle GJ, Carter CS, Thase ME. Use of FMRI to predict recovery from unipolar depression with cognitive behavior therapy. Am J Psychiatry. 2006 Apr;163(4):735-8. doi: 10.1176/ajp.2006.163.4.735.
Results Reference
result
PubMed Identifier
22945620
Citation
Siegle GJ, Thompson WK, Collier A, Berman SR, Feldmiller J, Thase ME, Friedman ES. Toward clinically useful neuroimaging in depression treatment: prognostic utility of subgenual cingulate activity for determining depression outcome in cognitive therapy across studies, scanners, and patient characteristics. Arch Gen Psychiatry. 2012 Sep;69(9):913-24. doi: 10.1001/archgenpsychiatry.2012.65.
Results Reference
result
PubMed Identifier
24643964
Citation
Horner MS, Siegle GJ, Schwartz RM, Price RB, Haggerty AE, Collier A, Friedman ES. C'mon get happy: reduced magnitude and duration of response during a positive-affect induction in depression. Depress Anxiety. 2014 Nov;31(11):952-60. doi: 10.1002/da.22244. Epub 2014 Mar 18.
Results Reference
result
Links:
URL
http://www.wpic.pitt.edu/research/pican/
Description
Program in Cognitive Affective Neuroscience website
URL
http://www.pitt.edu/~gsiegle/
Description
PI website

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Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression

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