Clinical trial NCT00896441
Conditions: Depression Mood Disorders Depressive Disorder
Sponsor: Stanford University
Start date: 2009-02-01; Completion date: 2014-06-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Depressed patients assigned in an open-label study of citalopram arm 2: Healthy controls used as a comparison (no intervention) group for change in resting-state fMRI over time
Interventions: intervention 1: Citalopram
Intervention descriptions: intervention 1: Refer to Detailed Description Section for full description of intervention. Week 1 (baseline): Subject will complete several tests to assess the subject's memory and concentration. Following visit, they will begin treatment with the antidepressant citalopram.

Week 1 MRI: Subject will have their first MRI. Week 2 visit: Physician will meet with they to assess the subject's overall condition.

Week 2 MRI: Subject will have the subject's second MRI. Week 4 visit: The study physician will meet with the subject to assess their overall condition.

Week 6 (Telephone check-in): The study physician will check in with the subject by telephone to assess the subject's overall condition.

Week 8: (End-of-study visit) Subject will take repeated tests of memory and concentration. The study physician will also discuss recommendations for further treatment of the subject's depression.

Week 8 MRI: Around the time of the subject's week 8 visit they will have the subject's third and final MRI.

Protocol documents: