Neural and Antidepressant Effects of Propofol

NCT03684447 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 00116093
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the antidepressant effects of propofol at two different doses while measuring potential treatment-related biomarkers.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale

  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 of 50% or greater

  approximately 17 days after randomization

Secondary Outcomes (1)

• Hamilton Depression Rating Scale

  approximately 36 days after randomization

Study Arms (2)

Propofol High Dose

EXPERIMENTAL

high propofol injectable, individually dosed, three times per week

Drug: Propofol

Propofol Low Dose

EXPERIMENTAL

low propofol injectable, individually dosed, three times per week

Drug: Propofol

Interventions

Propofol DRUG

Series of 6 treatments with propofol.

Also known as: Diprivan

Propofol High Dose

Eligibility Criteria

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

You may qualify if:

• Age 18-55 years 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 16-item Quick Inventory of Depressive Symptomatology, self-rated (QIDS) \> 10 24-item Hamilton Depression Rating Scale (HDRS) \> 18

You may not qualify if:

• Contraindication to propofol, egg lecithin, soybean oil, or other study drugs Lifetime history of a serious suicide attempt(Gvion and Levi-Belz, 2018) Recent suicidal behavior(past 3 months) Body mass index \> 40 kg/m2 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, moderate-to-severe(past 3 months) Obsessive compulsive disorder (past month) Post-traumatic stress disorder (past month) Schizophrenia-spectrum disorder (lifetime) Neurocognitive disorder (past year) Personality disorder as a current focus of treatment ECT within the past 3months Inappropriate for ECT, or poor response to ECT within the past 5 years Incompetent to provide consent

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University 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 Officials

• Brian J Mickey, MD, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants randomized to the high dose will exit the study after treatment. Participants randomized to the low dose who have not experienced response are able to crossover to the high dose.

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 25, 2018
• Study Start: April 21, 2019
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

US (1)