Neural and Antidepressant Effects of Propofol (Phase 2)

Phase 2

Withdrawn

• Conditions: Treatment Resistant Depression
• Interventions: Drug: Diprivan

• Registration Number: NCT03923361
• Lead Sponsor: University of Utah

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-16
• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-22
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-18
• Primary Completion: 2024-03
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propofol	Diprivan	-

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression	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%

Trial Locations

Locations (1)

Univeristy Neuropsychiatric Institute; 🇺🇸 Salt Lake City, Utah, United States