Sedation and Guided Education for Depression Study (SAGE)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Behavioral: Response-focused education; Behavioral: Diagnosis-focused education

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Theresa Lii, MD, MS; Phone Number: 650-264-9442; Email: psychedelicstudies@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Response-focused education; Patient education that is focused on treatment response	Behavioral: Response-focused education; Once participants recover from sedation, they will receive education that is focused on their response to treatment.
Active Comparator: Diagnosis-focused education; Patient education that is focused on the diagnosis of major depressive disorder	Behavioral: Diagnosis-focused education; Once participants recover from sedation, they will be provided education that is focused on their diagnosis of major depressive disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression severity	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.	From enrollment to 28 days after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation awareness	The modified Brice Questionnaire will be used to evaluate what the participant remembers between the time of induction and their awakening from sedation.	Immediately upon recovery from sedation
Participant expectations	Participants will be asked to rate how effective they expect their treatment to be on a scale from 0 (not effective at all) to 100 (completely effective) and indicate the amount of confidence they have on a scale from 0% to 100%.	From enrollment to 28 days after treatment
Sleep disturbance	The 8-item PROMIS Sleep Disturbance Short Form assesses an individual's perception of their sleep quality. Items are self-rated on a 5-point scale ranging from 1 ("Not at all") to 5 ("Very much"). Raw scores are converted to standardized T-scores, with higher a T-score representing more severe sleep disturbance.	From enrollment to 28 days after treatment
Anxiety symptoms	The 7-item Generalized Anxiety Disorder (GAD-7) Scale assesses the severity of anxiety symptomsover the past two weeks. Items are self-rated on a 4-point scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), reflecting the frequency of symptoms. Higher total scores indicate greater anxiety symptom severity.	From enrollment to 28 days after treatment
Anhedonia	The 14-item Snaith-Hamilton Pleasure Scale (SHAPS) measures an individual's capacity to experience pleasure from various activities over the past two weeks, the absence of which indicates anhedonia. Items are self-rated on a 4-point scale ranging from 0 ("Strongly disagree") to 3 ("Strongly agree"). Lower total scores indicate greater degree of anhedonia.	From enrollment to 28 days after treatment
Peace of mind	The 7-item Peace of Mind Scale assesses an individual's overall sense of inner calm and contentment. Items are self-rated on a 5-point scale ranging from 1 ("Not at all") to 5 ("All of the time"). Higher total scores reflect a greater sense of peace of mind.	From enrollment to 28 days after treatment
Emotion regulation	The 10-item Emotion Regulation Questionnaire (ERQ) assesses individual differences in the habitual use of cognitive reappraisal and expressive suppression strategies. Items are self-rated on a 7-point Likert scale. Higher scores on the cognitive reappraisal subscale indicate a greater tendency to reinterpret situations to manage emotions, while higher scores on the expressive suppression subscale indicate a greater tendency to inhibit outward emotional expression.	From enrollment to 28 days after treatment
Frontal EEG theta power	Electroencephalography (EEG) is a non-invasive technique that records electrical activity of the brain using electrodes placed on the scalp. Theta band (4 to 8 Hz) power in the frontal leads will be compared.	Immediately before sedation start to time of recovery from sedation
Adverse events	Safety will be assessed by tracking the number and severity of adverse events spontaneously reported by the participant and through surveillance of medical records (if available) by the research team. Suicidality will be specifically monitored using the Columbia Suicide Severity Rating Scale.	From treatment day to 28 days after treatment

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sedation; Propofol; Patient education; Electroencephalography; Antidepressant; Major depressive disorder
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 76737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data, study outcomes, and data dictionaries
• IPD Sharing Time Frame: Available upon request after publication of the trial's primary findings for up to 5 years.
• IPD Sharing Access Criteria: Researchers must submit a brief proposal and statistical analysis plan for review and approval by the investigators and execute a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No