Sedation and Guided Education for Depression Study
ConditionMajor Depressive Disorder (MDD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Diagnosis of major depressive disorder of at least moderate severity
Able to read, understand, and provide written informed consent
Disqualifiers
Pregnant or breastfeeding
Certain substance use disorders
Daily use of opioids and/or benzodiazepines
History of psychosis, schizophrenia, or schizoaffective disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Response-focused education
BehavioralOnce participants recover from sedation, they will receive education that is focused on their response to treatment.
Diagnosis-focused education
BehavioralOnce participants recover from sedation, they will be provided education that is focused on their diagnosis of major depressive disorder.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Response-focused educationActive comparator 1 intervention
Group B: Diagnosis-focused educationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-interventionSecondary outcomes
1
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-interventionOther outcomes
1
Self-rated depression symptoms
Patient Health Questionnaire-9 (PHQ-9)
Time frame
From 7 days pre-intervention to 14 days post-intervention2
Anxiety symptoms
The 7-item Generalized Anxiety Disorder (GAD-7) Scale assesses the severity of anxiety symptomsover the past two weeks. Items are self-rated on a 4-point scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), reflecting the frequency of symptoms. Higher total scores indicate greater anxiety symptom severity.
Time frame
From 7 days pre-intervention to 14 days post-intervention3
Sleep disturbance
The 8-item PROMIS Sleep Disturbance Short Form
Time frame
From 7 days pre-intervention to 14 days post-intervention4
Anhedonia
The 14-item Snaith-Hamilton Pleasure Scale (SHAPS) measures an individual's capacity to experience pleasure from various activities over the past two weeks, the absence of which indicates anhedonia. Items are self-rated on a 4-point scale ranging from 0 ("Strongly disagree") to 3 ("Strongly agree"). Lower total scores indicate greater degree of anhedonia.
Time frame
From 7 days pre-intervention to 14 days post-interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: