Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression

July 29, 2013 updated by: James Murrough

Ketamine Anesthesia to Enhance Efficacy and Tolerability of Electroconvulsive Therapy in Patients With Unipolar or Bipolar Depression

The primary objectives of this study are to investigate the potential for ketamine anesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease acute ECT-induced adverse cognitive effects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Electroconvulsive therapy (ECT) is one of the most robust antidepressant treatments available. However, there is the potential for significant acute and longer term adverse cognitive effects with ECT and the antidepressant response requires multiple treatment sessions, increasing risk of adverse effects. Further, antidepressant response to ECT is often less than maximal and relapse is common. Growing preclinical and clinical evidence of the rapid-acting antidepressant properties of the anesthetic agent ketamine suggests the use of ketamine anesthesia as a strategy to increase rate of response and shorten treatment course in the administration of ECT. In addition, preclinical and clinical evidence suggests the potential of ketamine to decrease the adverse cognitive effects associated with ECT.

The investigators propose a pilot study to measure both acute therapeutic efficacy and cognitive side effects of ECT using ketamine compared to methohexital in depressed patients. The investigators will also explore other parameters of ECT such as seizure duration and morphology, as well as hemodynamic and behavioral changes.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York City, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female patients: 18 to 59 years
  2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
  3. DSM IV MINI diagnosis of major depressive episode (MDD), unipolar or bipolar
  4. Pretreatment 24-item Hamilton Rating Scale for Depression score > 21
  5. ECT is clinically indicated
  6. Patient has the capacity to provide informed consent.

Exclusion Criteria:

  1. DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or mental retardation
  2. Current primary diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression
  3. Current diagnosis of delirium, dementia, or amnestic disorder
  4. Baseline Mini Mental State Exam (MMSE) score < 24 and a total score falling two standard deviations below the age- and education-adjusted mean
  5. Any active general medical condition or CNS disease which can affect cognition or response to treatment
  6. Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
  7. Lifetime history of ketamine or PCP abuse or dependence
  8. ECT within three months
  9. The presence of any known or suspected contraindication to methohexital or ketamine including but not limited to known allergic reactions to these agents, uncontrolled hypertension arrhythmia severe coronary artery disease and porphyria
  10. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine
Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Drug: Ketamine
Ketamine 1-2 mg/kg IV as indicated for ECT
Active Comparator: Methohexital
Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Drug: Methohexital
Methohexital 1 mg/kg IV as indicated for ECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression-24 (HRSD24)
Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks
The HDRS-24 is used to rate depressive symptoms. This instrument is considered one of the "gold standard" clinician-rated instruments for depressive symptoms. We have established procedures for the maintenance of inter-rater reliability.
Change from beginning of ECT treatment to end; on average 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)
Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks
The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).
Change from beginning of ECT treatment to end; on average 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James Murrough

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (Estimate)

March 7, 2011

Study Record Updates

Last Update Posted (Estimate)

August 30, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 09-2251
  • KETECT-MSSM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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