Sedation and Guided Education for Depression Study

N/ANot Yet RecruitingNCT06705270

Stanford University20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depressive Disorder (MDD)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in clinician-rated depression severity

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.

Time frame: From Day 0 pre-intervention baseline to 1, 2, and 3 days post-intervention

Secondary Outcomes

Antidepressant response rate

Defined as ≥50% reduction of MADRS scores from Day 0 pre-intervention baseline

Time frame: From Day 0 pre-intervention baseline to 1, 2, 3, 7, and 14 days post-intervention