Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285935
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2006-01-31
Brief Title:
Cellular Aging and Neurobiology of Depression Study
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Neurosteroid Metabolism and the Antidepressant Effects of Serotonin Specific Reuptake Inhibitors SSRIs
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAN-D
Brief Summary:
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 are also interested in how the gut microbiome is affected by antidepressant treatment
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
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
Detailed Description:
Following an initial telephone screen to assess inclusion and exclusion criteria the evaluation will continue with an in-person screening 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 is a baseline visit The baseline visit will last up to 35 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 180 cc After the blood draw participants will complete cognitive tests and meet again with the study psychiatrist Eligible consenting healthy controls will come in for a one time study visit and complete the same tests performed during the depressed subject baseline visit Both depressed participants and healthy controls will return a stool sample collected at home with a kit given during the screening visit
After the baseline visit 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 They will be given an at home collection kit to return a stool sample at the last study visit
4 weeks later after 8 weeks in total depressed participants will come back for an additional visit that will include the same blood draw and testing as the baseline visit They also will return their stool sample 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
The next step for eligible consenting depressed subjects and is a baseline visit The baseline visit will last up to 35 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 180 cc After the blood draw participants will complete cognitive tests and meet again with the study psychiatrist Eligible consenting healthy controls will come in for a one time study visit and complete the same tests performed during the depressed subject baseline visit Both depressed participants and healthy controls will return a stool sample collected at home with a kit given during the screening visit
After the baseline visit 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 They will be given an at home collection kit to return a stool sample at the last study visit
4 weeks later after 8 weeks in total depressed participants will come back for an additional visit that will include the same blood draw and testing as the baseline visit They also will return their stool sample 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K08MH126192 | NIH | None | httpsreporternihgovquickSearchK08MH126192 |
| R01MH083784 | NIH | None | None |