Treatment Resistant Depression
Conditions
Brief summary
Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.
Interventions
DRUGDiprivan
Similar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-55 * Diagnosis of major depressive disorder or bipolar disorder * Current moderate-to-severe depressive episode * Episode duration more than 2 months and less than 5 years * Failure of at least 2 adequate antidepressant medication trials within the past 2 years * Body mass index \< 40 * 16-item Quick Inventory of Depressive Symptomatology, self-rated \> 10
Exclusion criteria
* Contraindication to propofol or midazolam * Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication * Symptomatic coronary artery disease or heart failure * Poorly controlled hypertension or diabetes * Abnormal kidney or liver function * Pregnant or breast feeding * Traumatic brain injury or significant neurologic signs (past year) * Substance use disorder (past year) * Obsessive compulsive disorder (current) * Post-traumatic stress disorder (current) * Schizophrenia-spectrum disorder (lifetime) * Neurocognitive disorder (current) * Personality disorder as a current focus of treatment * ECT within the past 3 months * Inappropriate for ECT, or poor response to ECT within the past 5 years * Incompetent to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression | 3 weeks after baseline | 24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score \< 10 Response defined as decrease of total score from baseline \> 50% |
Countries
United States
Outcome results
None listed