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Depression study probes link between antidepressants, brain steroids, and gut bugs

NCT ID NCT00285935

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 228 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2010

Finished

Aug 2025

Lead sponsor

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

21 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • University of California San Francisco

    San Francisco, California, 94143-0984, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.