Sedation and Guided Education for Depression Study (SAGE)

Stanford University

Status: Not yet enrolling

Conditions: Major Depressive Disorder (MDD)

Treatments: Behavioral: Response-focused education; Behavioral: Diagnosis-focused education

Study type: Interventional

Funder types: Other

Identifiers

NCT06705270

76737

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Response-focused education

Active Comparator group

Description:

Patient education that is focused on treatment response

Treatment:

Behavioral: Response-focused education

Diagnosis-focused education

Active Comparator group

Description:

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

Treatment:

Behavioral: Diagnosis-focused education