Sedation and Guided Education for Depression Study

Study acronym: SAGE
StatusNot Yet Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Stanford University

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Enrollment increased: 20 → 40 participants
    • Interventions modified
    • Trial arms changed: 2 → 4
    • Eligibility criteria expanded, about 18 words
  2. Notable Primary endpoint(s) modified
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints expanded, about 3 words
  3. Notable Primary completion date: Mar 2027 to Sep 2028
    • Start date: Sep 2025 to Sep 2026
    • Study completion date: Apr 2027 to Oct 2028
    v3
  4. Notable Start date: Mar 2025 to Sep 2025v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
3,069 trials monitored
See 170 trials at risk
The goal of this clinical trial is to understand how patient education surrounding a one-time, consciousness-altering medical intervention impacts the antidepressant response to the intervention in adults with major depressive disorder. In this study, the consciousness-altering medical intervention is a single infusion of propofol, an intravenous anesthetic. In Part 1 of this study, we aim to answer: Does the focus of patient education influence the antidepressant response to a single intravenous infusion of propofol? In Part 2 of this study, we aim to answer: Does blocking opioid signaling affect the antidepressant response of patient education? Qualifying participants will: * Undergo a single intravenous infusion of propofol which will induce a temporary state of sedation * Wear an EEG cap that records brain activity during sedation * For Part 1: Be randomized to receive either response-focused or diagnosis-focused education about their brain signals after they recover from sedation. * For Part 2: Be randomized to receive a single dose of IV naloxone or IV saline during an educational intervention. * Be asked to fill out surveys about their mood and other measures of well-being throughout the study.
Trial Details
NCT Number NCT06705270
Lead Sponsor Stanford University
Conditions
(from sponsor)
Major Depressive Disorder (MDD)
Related terms Major Depressive Disorder
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov