Major Depressive Disorder (MDD)SAGENCT06705270
Sedation and Guided Education for Depression Study
A study testing Response-focused education, Diagnosis-focused education and IV naloxone in people with Major Depressive Disorder (MDD), run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Response-focused education, Diagnosis-focused education and IV naloxone
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depressive disorder of at least moderate severity
- Able to read, understand, and provide written informed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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?
Read more
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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Response-focused education, Diagnosis-focused education, IV naloxone, IV saline
- Keywords
- Propofol, Sedation, Patient education, Antidepressant, Major depressive disorder, Electroencephalography
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response-focused educationBehavioural
Once participants recover from sedation, they will receive education that is focused on their response to treatment.
Diagnosis-focused educationBehavioural
Once participants recover from sedation, they will be provided education that is focused on their diagnosis of major depressive disorder.
IV naloxoneDrug
A single dose of IV naloxone given during the educational intervention.
IV salineDrug
A single dose of IV saline given during the educational intervention.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Response-focused education | Active comparator | Patient education that is focused on treatment response Receives: Behavioral: Response-focused education |
| Part 1: Diagnosis-focused education | Active comparator | Patient education that is focused on the diagnosis of major depressive disorder Receives: Behavioral: Diagnosis-focused education |
| Part 2: IV naloxone during education | Experimental | Not described Receives: Drug: IV naloxone |
| Part 2: IV saline during education | Placebo comparator | Not described Receives: Drug: IV saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinician-rated depression severity 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.
Measured: Change from baseline (~1 week [7 ±2 days] prior to intervention day) averaged across post-intervention days 1, 2, and 3.
Secondary outcomes (2)
Antidepressant response rate
Defined as ≥50% reduction of MADRS scores from Day 0 pre-intervention baseline
Measured: 1, 2, and 3 days post-intervention
Remission rate
Defined as MADRS score ≤10
Measured: 1, 2, and 3 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 and Part 2 of this study are separate RCTs with 2 parallel arms each. Part 1: Response-focused education vs Diagnosis-focused education (n=20) Part 2: IV naloxone vs IV saline pretreatment (n=20)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Lii, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705270
- Sponsor's protocol ID
- 76737
- Acronym
- SAGE
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data, study outcomes, and data dictionaries
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Impact of Patient Education Strategies on the Antidepressant Response to Propofol Sedation
- ClinicalTrials.gov ID
- NCT06705270
- Acronym / sponsor ID
- SAGE / 76737
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Propofol, Sedation, Patient education, Antidepressant, Major depressive disorder, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Part 1 and Part 2 of this study are separate RCTs with 2 parallel arms each. Part 1: Response-focused education vs Diagnosis-focused education (n=20) Part 2: IV naloxone vs IV saline pretreatment (n=20)
| Arm | Type | Receives |
|---|---|---|
| Part 1: Response-focused education | Active comparator | Behavioral: Response-focused educationPatient education that is focused on treatment response |
| Part 1: Diagnosis-focused education | Active comparator | Behavioral: Diagnosis-focused educationPatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of major depressive disorder of at least moderate severity
- Able to read, understand, and provide written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Response-focused educationOnce participants recover from sedation, they will receive education that is focused on their response to treatment. | Behavioural | Part 1: Response-focused education |
| Diagnosis-focused educationOnce participants recover from sedation, they will be provided education that is focused on their diagnosis of major depressive disorder. | Behavioural | Part 1: Diagnosis-focused education |
| IV naloxoneA single dose of IV naloxone given during the educational intervention. | Drug | Part 2: IV naloxone during education |
| IV salineA single dose of IV saline given during the educational intervention. | Drug | Part 2: IV saline during education |
Primary outcome
Change in clinician-rated depression severity across post-intervention days 1, 2, and 3
Time frame: 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.
2 secondary outcomes
Antidepressant response rate
Time frame: 1, 2, and 3 days post-intervention
Remission rate
Time frame: 1, 2, and 3 days post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data, study outcomes, and data dictionaries
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Response-focused education, Diagnosis-focused education and IV naloxone in people with Major Depressive Disorder (MDD), run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theresa Lii, MD, MS (650-264-9442, sagestudy@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinician-rated depression severity across post-intervention days 1, 2, and 3 (time frame: Change from baseline (~1 week [7 ±2 days] prior to intervention day) averaged across post-intervention days 1, 2, and 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.