Exploring the relationship between cellular aging and depression

Neurosteroid Metabolism and the Antidepressant Effects of Serotonin Specific Reuptake Inhibitors (SSRI's)

This study is trying to see how natural compounds and genetic markers in the blood differ between people with depression and healthy individuals, and how these differences change with antidepressant treatment over eight weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 21 Years to 60 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT00285935 on ClinicalTrials.gov

What this trial studies

This study investigates differences in blood levels of natural compounds and genetic markers between individuals with Major Depressive Disorder (MDD) and healthy controls. It aims to understand how these differences relate to memory, mood, and neurobiology, as well as the impact of antidepressant treatment on the gut microbiome. Participants will undergo a baseline evaluation, followed by an eight-week treatment period with an FDA-approved antidepressant. The study will compare changes in depressed patients to matched healthy controls over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-60 who are experiencing Major Depressive Disorder and can provide informed consent.

Not a fit: Patients with significant uncontrolled medical illnesses or those currently on psychotropic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment of Major Depressive Disorder.

How similar studies have performed: Previous studies have shown promise in understanding the neurobiology of depression and the effects of SSRIs, making this approach both relevant and potentially impactful.

Eligibility criteria

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

Where this trial is running

San Francisco, California

• University of California San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Owen Wolkowitz, MD — University of California, San Francisco
• Study coordinator: Tiffany Chinn, BS

Conditions Major Depressive Disorder; MDD; Neurobiology; Selective Serotonin Reuptake Inhibitor; SSRI; Depression