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Ketamine Anesthesia in Electroconvulsive Therapy

NCT ID: NCT01367119

Last Updated: 2013-08-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-03-31

Brief Summary

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Does the use of ketamine as the anesthetic medication in electroconvulsive therapy (ECT) accelerate the antidepressant effect of ECT?

The study hypothesis was that depressed subjects receiving ECT with ketamine as the anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression ratings after the second ECT than depressed patients receiving ECT with the usual anesthetic agent.

Detailed Description

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There are several drugs available to induce anesthesia for electroconvulsive therapy (ECT), a psychiatric treatment for major depressive illness. The most commonly utilized of these include methohexital, thiopental, etomidate, and propofol. Recently, there has been interest in the use of ketamine in sub-anesthetic doses to treat major depressive illness.

In this randomized, blinded trial, depressed subjects scheduled to be treated with ECT were anesthetized with either ketamine or methohexital at doses of approximately 1.0 mg/kg for each drug. Patients received the same drug for up to six of their ECT treatments. Outcome measures included assessments of depressive severity, cognition, post-anesthesia side effects, and hemodynamics.

Subjects were to be followed with as long as they were receiving inpatient ECT treatments. The number of treatments was determined entirely by their primary psychiatric team, also blind to anesthetic, as per usual care. In other words, this study did not determine when to terminate the ECT course.

Conditions

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Depression

Keywords

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Depression Electroconvulsive therapy Ketamine Methohexital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ketamine

Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic.

Methohexital

Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.

Group Type ACTIVE_COMPARATOR

methohexital

Intervention Type DRUG

Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic.

Interventions

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Ketamine

Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic.

Intervention Type DRUG

methohexital

Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic.

Intervention Type DRUG

Other Intervention Names

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Ketalar Ketamine Hydrocholoride Brevital Sodium

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of depression, either unipolar or bipolar
* Subjects receiving ECT at the Mayo Clinic

Exclusion Criteria

* Subjects not giving their own consent to ECT
* Subjects with schizophrenia, schizoaffective disorder, or dementia
* Subjects diagnosed with a major neurological disorder such as epilepsy, Parkinson disease, multiple sclerosis, or a neurodegenerative dementia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Keith Rasmussen, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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11-001430

Identifier Type: -

Identifier Source: org_study_id