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

Official 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 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 228 participants

Interventions

• OTHER: Standard Clinical Care with an SSRI — Participants who enroll in this phase are treated with an FDA-approved SSRI in an open-label "treatment-as-usual" manner, in accordance with clinical practices and at a titration rate no more rapid than the manufacturer's recommendations. The duration of the treatment phase is 8 weeks. Other Name: fluoxetine (Prozac®), Sertraline (Zoloft®), citalopram (Celexa®), escitalopram (Lexapro®)

Primary Outcomes

• Depression ratings at baseline and Week 8 (baseline and Week 8)
• Serum levels of steroids and neurosteroids at baseline and Week 8 (baseline and Week 8)

Secondary Outcomes

• Serum levels of oxidative stress markers at baseline and Week 8 (baseline and Week 8)
• Serum levels of cytokines and immune markers at baseline and Week 8 (baseline and Week 8)

Trial Locations

• University of California San Francisco, San Francisco, California, United States

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