Sedation and Guided Education for Depression Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Response-focused education, Diagnosis-focused education.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial Comparing the Impact of Patient Education Strategies on the Antidepressant Response to Propofol Sedation
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
Interventions
- Behavioral Response-focused education
Once participants recover from sedation, they will receive education that is focused on their response to treatment. - Behavioral Diagnosis-focused education
Once participants recover from sedation, they will be provided education that is focused on their diagnosis of major depressive disorder.
Primary outcome measures
- Depression severity [Time frame: From enrollment to 28 days 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06705270 · 76737