Neural and Antidepressant Effects of Propofol (Phase 2)

• Status: Withdrawn
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Antidepressive Agents; Propofol

Criteria

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