Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT06705270

Sedation and Guided Education for Depression Study

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Response-focused education

Behavioral

Once participants recover from sedation, they will receive education that is focused on their response to treatment.

Diagnosis-focused education

Behavioral

Once participants recover from sedation, they will be provided education that is focused on their diagnosis of major depressive disorder.

Primary outcomes

  1. Change in clinician-rated depression severity

    Time frame: From Day 0 pre-intervention baseline to 1, 2, and 3 days post-intervention

    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.

Secondary outcomes

  1. Antidepressant response rate

    Time frame: From Day 0 pre-intervention baseline to 1, 2, 3, 7, and 14 days post-intervention

    Defined as ≥50% reduction of MADRS scores from Day 0 pre-intervention baseline

Other outcomes

  1. Self-rated depression symptoms

    Time frame: From 7 days pre-intervention to 14 days post-intervention

    Patient Health Questionnaire-9 (PHQ-9)

  2. Anxiety symptoms

    Time frame: From 7 days pre-intervention to 14 days post-intervention

    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.

  3. Sleep disturbance

    Time frame: From 7 days pre-intervention to 14 days post-intervention

    The 8-item PROMIS Sleep Disturbance Short Form

  4. Anhedonia

    Time frame: From 7 days pre-intervention to 14 days post-intervention

    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.

  5. Participant expectations

    Time frame: From 7 days pre-intervention to 14 days post-intervention

    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%.

  6. Perceived EEG credibility for depression symptoms

    Time frame: Immediately after the educational intervention

    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).

  7. Sedation awareness

    Time frame: Immediately upon recovery from sedation

    The modified Brice Questionnaire will be used to evaluate what the participant remembers between the time of induction and their awakening from sedation.

  8. Resting state alpha peak frequency

    Time frame: Baseline (prior to infusion)

    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.

  9. Resting state frontal theta power

    Time frame: Baseline (prior to infusion)

    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.

  10. Adverse events

    Time frame: From enrollment to 14 days post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Theresa Lii, MD, MS

CONTACT

[email protected]

650-264-9442

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: SAGE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 26, 2024
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.