Neural and Antidepressant Effects of Propofol (Phase 2)

Utah System of Higher Education (USHE)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Treatment Resistant Depression

Treatments: Drug: Diprivan

Study type: Interventional

Funder types: Other

Identifiers

NCT03923361

00116093B

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Propofol

Experimental group

Treatment:

Drug: Diprivan