Functional MRI Before and After Treatment for Depression
Functional MRI Before and After Treatment for Depression
The purpose of this study is to help us understand how depression changes brain activity and
 how this relates to mood, anxiety, and cognitive functions like memory. We also hope to
 develop a brain imaging test that will predict either before or within two weeks of starting
 a medicine whether the treatment will work.
You were selected as a possible participant because you are suffering from a major depressive
 episode, and you have not previously tried the medication used in this study to treat
 depression. Approximately 60 subjects will participate in this study: 30 subjects who are
 currently suffering from a major depressive episode and 30 subjects who have never suffered
 from a major depressive episode.

 If you choose to participate, you will be seen at the clinic for a total of five times plus
 three MRI scans. You will be seen once for a screening visit. If you choose to enroll, you
 will return a week later for the baseline visit and again at weeks 2, 4 and 8. Around the
 time of week one (baseline), week 2 and week 8 you will also undergo an MRI scan of the
 brain.

 Screening Visit: The study physician and the research study staff will first screen you for
 eligibility. The screening visit includes meeting with a physician for a discussion of your
 medical history and current medications, taking your blood pressure, and checking your
 weight. Women of childbearing potential will also have a urine pregnancy test. You will meet
 with a member of the research staff for an interview to collect information about your
 depression and other psychiatric symptoms you have experienced. The purpose of the interview
 is to confirm your diagnosis and assess the current severity of your depression. The
 screening visit will take approximately 2 hours.

 Week 1 (baseline): If you are eligible to continue with the study, you will return to the
 clinic within 7 days for a baseline visit. At your baseline visit, you will complete several
 tests to assess your memory and concentration. These tests are being conducted because
 problems with memory and concentration are common in people who are depressed and the
 researchers want to find out if there is a difference in your memory and concentration before
 and after taking the study medication. We also wish to compare the results to any findings
 from the brain imaging. Following the baseline visit, you will begin treatment with the
 antidepressant citalopram. The starting dose is 20 mg once per day.

 Week 1 MRI: Around the time of your week one (baseline) visit and before starting
 medications, you will have your first MRI.

 Week 2 visit: At the end of your second week, the study physician will meet with you to
 assess your overall condition. Your antidepressant medication will be counted to verify that
 you have been taking it as prescribed. Your dose will likely not change, but it is possible
 that it will be increased to as much as 40 mg. If you are experiencing side effects, your
 dose may be decreased. We will provide you with enough medication to last until your next
 visit.

 Week 2 MRI: Around the time of your week 2 visit you will have your second MRI.

 Week 4 visit: The study physician will meet with you to assess your overall condition. Your
 antidepressant medication will be counted to verify that you have been taking it as
 prescribed. The dose may be left unchanged, increased up to a total of 40 mg daily or
 decreased, if you are experiencing side effects (to a minimum of 20 mg daily). You will also
 be asked about any other medications you have taken since your last visit. We will provide
 you with enough medication to last until your next visit.

 Week 6 (Telephone check-in): The study physician will check in with you by telephone to
 assess your overall condition. The dose of the citalopram may be left unchanged, increased to
 a maximum of 60 mg daily or decreased (to a minimum to 20 m daily) if you are experiencing
 side effects.

 Week 8: (End-of-study visit) In addition to the usual visit procedures, the end-of-study
 visit will include repeated tests of memory and concentration. The study physician will also
 discuss recommendations for further treatment of your depression. No study medication will be
 dispensed at this visit.

 Week 8 MRI: Around the time of your week 8 visit you will have your third and final MRI.
Inclusion Criteria:

 Patients will be aged 18-65, have no significant neurologic history, must meet DSM-IV
 criteria for a diagnosis of major depression and be free of antidepressant or other
 psychotropic medication for a minimum of two weeks before enrollment. If a subject is
 talking psychiatric medication he/she may be weaned off of the medication by their treating
 physician prior to study enrollment. Such a course of action would only be advised if the
 current medication was not considered to be of any benefit to the subject. In particular,
 if a patient is on antidepressant medication which is of benefit, we would not advise
 tapering off medication -- and subsequent risk of relapse -- in order to participate in the
 study. The same line of thinking applies to all psychiatric diagnoses and associated
 medications candidate subjects may be taking.

 Exclusion Criteria:

 1. Significant head trauma with loss of consciousness.

 2. Active abuse of alcohol or illegal substances.

 3. Excluded psychiatric diagnoses include: Bipolar Affective Disorder, primary psychotic
 disorders (Schizophrenia, Schizoaffective disorder), Obsessive-Compulsive Disorder

 4. Pregnant or nursing women.

 5. Any contraindication to being scanned in the 3T scanner at the Lucas Center such as
 having a pacemaker or any implanted device that has not been cleared for scanning at 3
 Tesla.

 6. Any significant neurologic history (i.e. seizure, stroke, multiple sclerosis).

 7. Use of psychotropic medications within 2 weeks of enrollment.