Status:
COMPLETED
Cellular Aging and Neurobiology of Depression Study
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
21-60 years
Phase:
NA
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 ...
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 medica...
Eligibility Criteria
Inclusion
- All participants must meet the following criteria:
- Age 21-60 and able to give informed consent.
- Not "needle phobic," by self-report.
- English-speaking (to allow accurate use of behavioral rating scales and verbal cognitive tests).
- Females of child-bearing capacity must be non-pregnant (confirmed by urine pregnancy test) and using effective non-hormonal birth control (e.g. abstinence, condoms, IUD).
- Good general medical health; no significant uncontrolled illnesses that will invalidate the designated outcome measures.
- Clinical labs (electrolytes, liver function test, CBC) with no clinically significant abnormalities that result in medical treatment that will invalidate the designated outcome measures.
- Negative urine toxicology (drugs of abuse) screen.
- Taking no medication or drugs likely to interfere with the study objectives (including statins or medications that affect hormones \[e.g. birth control pills or steroids\]).
- Free of all psychotropic medications (including antidepressants) for at least 6 weeks (with the exception of prn short-acting benzodiazepines or sedative-hypnotics, \< 3 doses per week, and none for 5 drug half-lives before the study).
- No vaccines for at least 4 weeks prior to baseline blood draw (including the flu shot).
- Not currently anemic (Hct of 36-48 for females and 38-54 for males, or Hgb of 12.5-20) and has not donated blood for at least 8 weeks prior to baseline blood draw.
- No neurological disorders and no history of concussion with a black-out that lasted \> 10 minutes.
- Willing to provide stool sample
- Additional criteria for Depressed Participants:
- Current DSM-5 diagnosis of Major Depressive Disorder, unipolar, with non-psychotic features.
- Baseline 17-item Hamilton Depression Rating Scale (HDRS) rating of \>= 17, or Baseline 25-item HDRS rating of \>= 20.
- Current depressive episode duration of \> 6 weeks.
- No current, active suicidal intent; HDRS "suicidality" item rating \<= 2 OR by clinician determination.
- No recent (\< 6 month) history of substance or alcohol use disorder(s), with the exception of tobacco use (DSM-5 criteria).
- No current (in the last month) diagnosis of Post-Traumatic Stress Disorder (DSM-5 criteria).
- No anticipated changes in psychotherapeutic interventions during the course of the study.
- Additional criteria for Normal Controls:
- • No history of DSM-5 Axis I diagnoses
Exclusion
Key Trial Info
Start Date :
December 16 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 22 2025
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00285935
Start Date
December 16 2010
End Date
August 22 2025
Last Update
September 23 2025
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143-0984