Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 55
Updated:1/30/2019
Start Date:June 2008
End Date:July 2011

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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.

Same as above.

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.
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