Neural and Antidepressant Effects of Propofol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-21

Study Completion Date

2024-07-31

Brief Summary

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

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Detailed Description

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Aim 1: Compare the clinical antidepressant effects of high-dose versus low-dose propofol.

Aim 2: Characterize the dose-dependent effects of propofol on brain function and gene expression

Conditions

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Treatment Resistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Propofol High Dose

high propofol injectable, individually dosed, three times per week

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Series of 6 treatments with propofol.

Propofol Low Dose

low propofol injectable, individually dosed, three times per week

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Series of 6 treatments with propofol. May be able to cross over and receive 6 additional treatments with the high dose of propofol.

Interventions

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Propofol

Series of 6 treatments with propofol.

Intervention Type DRUG

Propofol

Series of 6 treatments with propofol. May be able to cross over and receive 6 additional treatments with the high dose of propofol.

Intervention Type DRUG

Other Intervention Names

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Diprivan Diprivan

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No