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NCT06705270Not yet recruiting

Sedation and Guided Education for Depression Study

Randomized Controlled Trial Comparing the Impact of Patient Education Strategies on the Antidepressant Response to Propofol Sedation

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
20 Nov 2024
Start date
1 Sept 2026
Primary completion date
30 Sept 2028
Lead sponsor
Stanford University
Diseases
Depression
NCT number
NCT06705270

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 1 Sept 2026 to the primary completion date, 30 Sept 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Certain substance use disorders
  • History of psychosis, schizophrenia, or schizoaffective disorder
  • Any gastrointestinal condition placing the patient at significant risk of aspiration
  • Any medical condition that unacceptably increases the risk of propofol sedation

Other

  • Pregnant or breastfeeding
  • Daily use of opioids and/or benzodiazepines
  • Body mass index greater than 35 kg/m2
  • Obstructive sleep apnea that is moderate and untreated, or severe

Who the study is looking for

  • Diagnosis of major depressive disorder of at least moderate severity
  • Able to read, understand, and provide written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.