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WithdrawnNCT03923361Updated Dec 18, 2019

Neural and Antidepressant Effects of Propofol (Phase 2)

A Phase 2/3 interventional study of Diprivan in Treatment Resistant Depression, sponsored by University of Utah. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-12-18.

Sponsored by University of Utah · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
Change in study design based on phase 1 data collection; patient burden was not feasible
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Treatment Resistant Depression
03

In context

Depressive Disorder, Treatment-Resistant

472 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 151 are open to participants now.

Browse Depressive Disorder, Treatment-Resistant studies →

Lead sponsor

University of Utah is the lead sponsor of 991 studies on the registry; 177 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 64 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Propofol

    Drug: Diprivan

Interventions

  • 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.

    Also known as: Propofol

06

What researchers measure

Primary outcomes

  1. Hamilton Rating Scale for Depression

    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%

    Time frame: 3 weeks after baseline

07

Study locations

1 site
  • Univeristy Neuropsychiatric Institute
    Salt Lake City, Utah 84108, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03923361
Lead sponsor
University of Utah
Responsible party
Brian Mickey (Principal Investigator, University of Utah) — Principal investigator
First posted
Apr 22, 2019
Start date
Apr 16, 2019
Primary completion
Mar 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Dec 18, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Propofol

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