a study on Depression
We are conducting an eight week longitudinal study to learn if blood levels of certain naturally occurring compounds and genetic markers differ between patients with depression and healthy adults who are not depressed, and if any such differences relate to memory performance, mood, and neurobiology. We will do this by comparing the unmedicated depressed patients with matched healthy controls at baseline and then following the depressed patients over the course of eight weeks of standardized antidepressant treatment to gauge which baseline abnormalities normalize over the course of treatment.
Neurosteroid Metabolism and the Antidepressant Effects of Serotonin Specific Reuptake Inhibitors (SSRI's)
Following an initial telephone screen to assess inclusion and exclusion criteria, the evaluation will continue with an in-person evaluation to assess the presence or absence of active medical history and history of major psychiatric illness, as well as review of the consent document. If found to be eligible, participants would then be admitted to the study.
The next step for eligible, consenting depressed subjects and healthy controls is a baseline hospital visit and baseline MRI. The baseline hospital visit will last about 4 hours. We will begin the baseline visit by collecting a urine sample for a drug (and, for women, pregnancy) test. As long as that is negative, we will then collect a blood sample of about 135cc. After the blood draw, participants will complete cognitive tests and meet again with the study psychiatrist. Participants will also complete a baseline Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) of their brain at the Veteran's Affairs (VA) Hospital in San Francisco.
After the baseline hospital visit and MRI, depressed subjects (but not healthy controls) will begin taking an FDA approved antidepressant, as prescribed by the study psychiatrist, for the next 8 weeks while they are enrolled in the study. The specific drug will be decided upon between the participant and the study psychiatrist at the in-person screening visit.
After 4 weeks, depressed participants will return to UCSF to meet again with the psychiatrist to discuss symptoms and how to continue treatment; at that visit, they will have another blood draw of 135cc (the same blood draw as at baseline). Healthy controls will return at week 4 only for the blood draw.
4 weeks later (after 8 weeks in total), we will bring both depressed and healthy participants back for an additional visit that will include the same blood draw, testing, and MRI as the baseline visit. A physician-investigator will meet with the depressed subjects to review their clinical responses to treatment and to make further treatment suggestions, which the subjects may use in discussions of their future treatment options with their personal physicians. If a decision is made to discontinue antidepressant treatment, the subjects will be given instructions on how to withdraw from the medication, and will be given up to a 4 week supply of the drug to facilitate this withdrawal.
Major Depressive Disorder MDD Neurobiology Selective Serotonin Reuptake Inhibitor SSRI Depression Serotonin Serotonin Uptake Inhibitors
For people ages 21–60
All participants must meet the following criteria:
Additional criteria for Depressed Participants:
2.5 years since initial onset of depression and current depressive episode duration of> 6 weeks.
Additional criteria for Normal Controls:
• No history of DSM-5 Axis I diagnoses
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT00285935.
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