Neural and Antidepressant Effects of Propofol (Phase 2)

December 13, 2019 updated by: Brian Mickey, University of Utah
Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Propofol
Drug: Diprivan
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.
Other Names:
  • Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression
Time Frame: 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%
3 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 16, 2019

Primary Completion (ANTICIPATED)

March 1, 2024

Study Completion (ANTICIPATED)

July 1, 2024

Study Registration Dates

First Submitted

April 19, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (ACTUAL)

April 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00116093B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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