Cellular Aging and Neurobiology of Depression Study (CAN-D)
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.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Neurosteroid Metabolism and the Antidepressant Effects of Serotonin Specific Reuptake Inhibitors (SSRI's)|
- Depression ratings at baseline and Week 8 [ Time Frame: baseline and Week 8 ] [ Designated as safety issue: No ]
- Serum levels of steroids and neurosteroids at baseline and Week 8 [ Time Frame: baseline and Week 8 ] [ Designated as safety issue: No ]
- Serum levels of oxidative stress markers at baseline and Week 8 [ Time Frame: baseline and Week 8 ] [ Designated as safety issue: No ]
- Serum levels of cytokines and immune markers at baseline and Week 8 [ Time Frame: baseline and Week 8 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||February 2020|
|Estimated Primary Completion Date:||February 2020 (Final data collection date for primary outcome measure)|
Experimental: Treatment with SSRI
Depressed participants will receive 8 weeks of treatment with one of the following serotonin-specific reuptake inhibitors:
fluoxetine (Prozac®), sertraline (Zoloft®), paroxetine (Paxil®), citalopram (Celexa®), escitalopram (Lexapro®)
The specific drug used for treatment will be selected by the study clinician based on clinical interviews and the participants preferences. Participants will be monitored for response and side effects by study clinician and will return after 8 weeks for a follow up study visit.
Drug: Treatment with SSRI
Participants who enroll in this phase are treated with an FDA-approved SSRI in an open-label "treatment-as-usual" manner, in accordance with clinical practices and at a titration rate no more rapid than the manufacturer's recommendations. The duration of the treatment phase is 8 weeks.
Other Name: fluoxetine (Prozac®), Sertraline (Zoloft®), paroxetine (Paxil®), citalopram (Celexa®), escitalopram (Lexapro®)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285935
|Contact: Owen Wolkowitz, MD||415-476-7433||Owen.Wolkowitz@ucsf.edu|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94143-0984|
|Contact: Owen Wolkowitz, MD 415-476-7433 Owen.Wolkowitz@ucsf.edu|
|Principal Investigator:||Owen Wolkowitz, MD||University of California, San Francisco|