Sedation and Guided Education for Depression Study

NCT ID: NCT06705270

Last Updated: 2025-05-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-04-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Response-focused education

Patient education that is focused on treatment response

Group Type: ACTIVE_COMPARATOR

Response-focused education

Intervention Type: BEHAVIORAL

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

Diagnosis-focused education

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

Group Type: ACTIVE_COMPARATOR

Diagnosis-focused education

Intervention Type: BEHAVIORAL

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

Interventions

Response-focused education

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

Intervention Type: BEHAVIORAL

Diagnosis-focused education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Theresa Lii

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Theresa Lii, MD, MS

Role: CONTACT

psychedelicstudies@stanford.edu

650-264-9442

Other Identifiers

76737

Identifier Type: -

Identifier Source: org_study_id