Randomized Controlled Trial Comparing the Impact of Patient Education Strategies on the Antidepressant Response to Propofol Sedation
| Registry | NCT06705270, acronym SAGE |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 40 (Estimated) |
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| Sponsor | Stanford University (Other) |
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| Conditions | Major Depressive Disorder (MDD) |
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| Interventions | Response-focused education, Diagnosis-focused education, IV naloxone, IV saline (Behavioral, drug) |
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| Dates | start 2026-09-01 (estimated), primary completion 2028-09-01 (estimated), completion 2028-10-01 (estimated), first posted 2024-11-26, last updated 2026-10-27 |
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-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.
In Part 1 of this study, we aim to answer: Does the focus of patient education influence the antidepressant response to a single intravenous infusion of propofol?
In Part 2 of this study, we aim to answer: Does blocking opioid signaling affect the antidepressant response of patient 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
* For Part 1: Be randomized to receive either response-focused or diagnosis-focused education about their brain signals after they recover from sedation.
* For Part 2: Be randomized to receive a single dose of IV naloxone or IV saline during an educational intervention.
* Be asked to fill out surveys about their mood and other measures of well-being throughout the study.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Part 1: Response-focused education | Active comparator | Behavioral: Response-focused education | Patient education that is focused on treatment response |
| Part 1: Diagnosis-focused education | Active comparator | Behavioral: Diagnosis-focused education | Patient education that is focused on the diagnosis of major depressive disorder |
| Part 2: IV naloxone during education | Experimental | Drug: IV naloxone | |
| Part 2: IV saline during education | Placebo comparator | Drug: IV saline | |
- 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.
- IV naloxone (Drug): A single dose of IV naloxone given during the educational intervention.
- IV saline (Drug): A single dose of IV saline given during the educational intervention.
+Outcome measures
Primary outcomes
- Change in clinician-rated depression severity across post-intervention days 1, 2, and 3 [Change from baseline (~1 week [7 ±2 days] prior to intervention day) averaged across post-intervention days 1, 2, and 3.]: 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
- Antidepressant response rate [1, 2, and 3 days post-intervention]: Defined as ≥50% reduction of MADRS scores from Day 0 pre-intervention baseline
- Remission rate [1, 2, and 3 days post-intervention]: Defined as MADRS score ≤10
Other outcomes
- Self-rated depression symptoms [From 7 days pre-intervention to 14 days post-intervention]: Patient Health Questionnaire-9 (PHQ-9)
- Anxiety symptoms [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.
- Sleep disturbance [From 7 days pre-intervention to 14 days post-intervention]: The 8-item PROMIS Sleep Disturbance Short Form
- Anhedonia [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.
- Participant expectations [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%.
- Perceived EEG credibility for depression symptoms [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).
- Sedation awareness [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.
- Resting state alpha peak frequency [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.
- Resting state frontal theta power [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.
- Adverse events [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.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Diagnosis of major depressive disorder of at least moderate severity
* Able to read, understand, and provide written informed consent
Exclusion Criteria includes, but is not limited to:
* 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
* Any medical condition that unacceptably increases the risk of propofol sedation
+Study documents