Burst Suppression Anesthesia for Treatment of Severe Depression

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-09-30

Brief Summary

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This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.

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Detailed Description

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Ten individuals with treatment resistant major depressive disorder will undergo 10 treatments of deep anesthesia via propofol over a 3-week period. Depression will be evaluated before and after treatment.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol

Participants will receive intravenous propofol titrated rapidly at 100-200 mcg/kg/min to reach 80% burst-suppression and then maintained there for 15 minutes, after which propofol administration will be discontinued and the participant will be allowed to awaken.

Group Type EXPERIMENTAL

Diprivan

Intervention Type DRUG

Interventions

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Diprivan

Intervention Type DRUG

Other Intervention Names

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Propofol

Eligibility Criteria

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Inclusion Criteria

* • Diagnosis of Major Depressive Disorder (MDD) or bipolar Disorder (I or II, most recent episode must be depression

* Failed at least 2 anti-depressant treatments and no ECT in past 6 months
* Age between 18-55 years
* BMI \< 35
* Hamilton Rating Scale for Depression (HSRD) score \> 18
* Quick Inventory of Depression Scale (QIDS) score \> 10.

Exclusion Criteria

* • Diagnosis of primary psychotic disorder, dysthymia, or personality disorder

* Significant pre-morbid cognitive impairment
* Hypertension and current use of ACE inhibitor or AR blocker medications
* Symptomatic coronary artery disease or congestive heart failure
* History of transient ischemic or neurologic signs during the past year
* History of or susceptibility to malignant hyperthermia
* Contraindication to isoflurane or propofol anesthesia (as determined by anesthesiologist)
* Diabetes requiring insulin
* Poor kidney function
* Chronic use of benzodiazepines or opioids
* Individuals incompetent to provide consent (e.g. catatonic, psychotic).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No