Clinical trial NCT06705270: Sedation and Guided Education for Depression Study
Official title: Randomized Controlled Trial Comparing the Impact of Patient Education Strategies on the Antidepressant Response to Propofol Sedation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: Propofol
Sedation
Patient education
Antidepressant
Major depressive disorder
Electroencephalography
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Depression severity
timeFrame: From enrollment to 28 days after treatment
Secondary outcomes:
Other outcomes:
measure: Sedation awareness
timeFrame: Immediately upon recovery from sedation
measure: Participant expectations
timeFrame: From enrollment to 28 days after treatment
measure: Sleep disturbance
timeFrame: From enrollment to 28 days after treatment
measure: Anxiety symptoms
timeFrame: From enrollment to 28 days after treatment
measure: Anhedonia
timeFrame: From enrollment to 28 days after treatment
measure: Peace of mind
timeFrame: From enrollment to 28 days after treatment
measure: Emotion regulation
timeFrame: From enrollment to 28 days after treatment
measure: Frontal EEG theta power
timeFrame: Immediately before sedation start to time of recovery from sedation
measure: Adverse events
timeFrame: From treatment day to 28 days after treatment
Locations:
Study officials:
References: