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

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. Depression severity

    Time frame: 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.

Other outcomes

  1. 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.

  2. Participant expectations

    Time frame: From enrollment to 28 days after treatment

    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%.

  3. Sleep disturbance

    Time frame: From enrollment to 28 days after treatment

    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.

  4. Anxiety symptoms

    Time frame: From enrollment to 28 days after treatment

    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.

  5. Anhedonia

    Time frame: From enrollment to 28 days after treatment

    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.

  6. Peace of mind

    Time frame: From enrollment to 28 days after treatment

    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.

  7. Emotion regulation

    Time frame: From enrollment to 28 days after treatment

    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.

  8. Frontal EEG theta power

    Time frame: Immediately before sedation start to time of recovery from sedation

    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.

  9. Adverse events

    Time frame: From treatment day to 28 days after treatment

    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
Apr 24, 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.

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