Depression study probes link between antidepressants, brain steroids, and gut bugs
NCT ID NCT00285935
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This completed study from the University of California, San Francisco enrolled 228 adults with major depression and healthy volunteers. Researchers measured blood levels of natural steroids, genetic markers, and gut bacteria before and after 8 weeks of standard SSRI treatment. The goal was to understand how these factors relate to mood and memory, and how antidepressants might work.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SSRI antidepressants (fluoxetine, sertraline, citalopram, escitalopram)
- What this could lead to
- If successful, this could help explain how antidepressants work and point to new ways to predict or personalize depression treatment.
- What could go wrong
- This is an observational study, not a treatment trial. It looks at biological markers, so it won't directly test a new therapy. Results may not lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 228 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2010
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of California San Francisco
San Francisco, California, 94143-0984, United States
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