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: sagestudy@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
Change in clinician-rated depression severity	The Montgomery-Asberg Depression Rating Scale (MADRS) assesses the severity of depressive symptoms experienced by an individual. Items are clinician-rated on a 7-point scale tailored to each depression-related symptom (e.g. sleep, appetite, energy level). Higher total scores indicate greater depression symptom severity.	From Day 0 pre-intervention baseline to 1, 2, and 3 days post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antidepressant response rate	Defined as ≥50% reduction of MADRS scores from Day 0 pre-intervention baseline	From Day 0 pre-intervention baseline to 1, 2, 3, 7, and 14 days post-intervention

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
Self-rated depression symptoms	Patient Health Questionnaire-9 (PHQ-9)	From 7 days pre-intervention to 14 days post-intervention
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 7 days pre-intervention to 14 days post-intervention
Sleep disturbance	The 8-item PROMIS Sleep Disturbance Short Form	From 7 days pre-intervention to 14 days post-intervention
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 7 days pre-intervention to 14 days post-intervention
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 7 days pre-intervention to 14 days post-intervention
Perceived EEG credibility for depression symptoms	Participants will be asked to rate how much their EEG credibly reflects their current depression symptoms on a scale from 0 (none at all) to 100 (completely).	Immediately after the educational intervention
Resting state alpha peak frequency	Peak frequency (Hz) within the alpha band (8-13 Hz) of the eyes-closed resting-state EEG power spectrum at occipital electrodes, derived via Fast Fourier Transform (FFT) spectral analysis.	Baseline (prior to infusion)
Resting state frontal theta power	Relative power within the theta band (4-8 Hz) of the eyes-closed resting-state EEG power spectrum at frontal electrodes, derived via Fast Fourier Transform (FFT) spectral analysis.	Baseline (prior to infusion)
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 enrollment to 14 days post-intervention

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): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 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