Sedation and Guided Education for Depression Study

Not Applicable

Not yet recruiting

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT06705270
• Lead Sponsor: Stanford University

Brief Summary

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 which might have antidepressant properties.

The main question this study aims to answer is: Does the focus of patient education influence the antidepressant response to a single intravenous infusion of propofol?

Researchers will compare response-focused vs. diagnosis-focused 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

* Be randomized to receive either response-focused or diagnosis-focused education about their brain signals after they recover from sedation

* Be asked to fill out surveys about their mood and other measures of well-being before and after treatment

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-26
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-19
• Study Start: 2025-09
• Primary Completion: 2027-03
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Pregnant or breastfeeding
• Certain substance use disorders
• Daily use of opioids and/or benzodiazepines
• History of psychosis, schizophrenia, or schizoaffective disorder
• Body mass index greater than 35 kg/m2
• Obstructive sleep apnea that is moderate and untreated, or severe
• Any gastrointestinal condition placing the patient at significant risk of aspiration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression severity	From enrollment to 28 days after treatment	The 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR-16) assesses the severity of depressive symptoms experienced by an individual. Items are self-rated on a 4-point scale tailored to each depression symptom. Higher total scores indicate greater depression severity.