Major Depressive Disorder (MDD)
Conditions
Keywords
Propofol, Sedation, Patient education, Antidepressant, Major depressive disorder, Electroencephalography
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
Interventions
BEHAVIORALResponse-focused education
Once participants recover from sedation, they will receive education that is focused on their response to treatment.
BEHAVIORALDiagnosis-focused education
Once participants recover from sedation, they will be provided education that is focused on their diagnosis of major depressive disorder.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinician-rated depression severity | From Day 0 pre-intervention baseline to 1, 2, and 3 days post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antidepressant response rate | From Day 0 pre-intervention baseline to 1, 2, 3, 7, and 14 days post-intervention | Defined as ≥50% reduction of MADRS scores from Day 0 pre-intervention baseline |
Contacts
CONTACTTheresa Lii, MD, MS
Outcome results
None listed