Neural and Antidepressant Effects of Propofol (Phase 2)

NCT03923361 | Withdrawn Phase 2

• 1 other identifier: 00116093B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Treatment Resistant Depression

Outcome Measures

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%

  3 weeks after baseline

Study Arms (1)

Propofol

EXPERIMENTAL

Drug: Diprivan

Interventions

Diprivan DRUG

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

Propofol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• item Quick Inventory of Depressive Symptomatology, self-rated \> 10

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Univeristy Neuropsychiatric Institute

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Propofol

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 22, 2019
• Study Start: April 16, 2019
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

US (1)