Sedation and Guided Education for Depression Study

NCT06705270 | Not Yet Recruiting

• 1 other identifier: 76737
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Conditions

Major Depressive Disorder (MDD)

Keywords

Propofol; Sedation; Patient education; Antidepressant; Major depressive disorder; Electroencephalography

Outcome Measures

Primary Outcomes (1)

• Depression severity

  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.

  From enrollment to 28 days after treatment

Other Outcomes (9)

• Sedation awareness

  Immediately upon recovery from sedation

• Participant expectations

  From enrollment to 28 days after treatment

• Sleep disturbance

  From enrollment to 28 days after treatment

Study Arms (2)

Response-focused education

ACTIVE COMPARATOR

Patient education that is focused on treatment response

Behavioral: Response-focused education

Diagnosis-focused education

ACTIVE COMPARATOR

Patient education that is focused on the diagnosis of major depressive disorder

Behavioral: Diagnosis-focused education

Interventions

Response-focused education BEHAVIORAL

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

Response-focused education

Diagnosis-focused education BEHAVIORAL

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

Diagnosis-focused education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of major depressive disorder of at least moderate severity
• Able to read, understand, and provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Theresa Lii, MD, MS

CONTACT

650-264-9442; psychedelicstudies@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 26, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 19, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Available upon request after publication of the trial's primary findings for up to 5 years.
• 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.