NCT00285935Completed
Cellular Aging and Neurobiology of Depression Study
Neurosteroid Metabolism and the Antidepressant Effects of Serotonin Specific Reuptake Inhibitors (SSRI's)
Source: ClinicalTrials.gov · Last updated 23 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- First submitted
- 31 Jan 2006
- Start date
- 16 Dec 2010
- Primary completion date
- 20 Aug 2025
- Lead sponsor
- University of California, San Francisco
- Diseases
- Depression
- NCT number
- NCT00285935
What you commit to
- Study type: Interventional
- Planned participants: 228
- From 16 Dec 2010 to the primary completion date, 20 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 21 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.