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

Primary Purpose

Major Depression, Bipolar Depression

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ketamine

Methohexital

About this trial

This is an interventional treatment trial for Major Depression focused on measuring depression, electroconvulsive therapy, ketamine, antidepressant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or mental retardation
Current primary diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression
Current diagnosis of delirium, dementia, or amnestic disorder
Baseline Mini Mental State Exam (MMSE) score < 24 and a total score falling two standard deviations below the age- and education-adjusted mean
Any active general medical condition or CNS disease which can affect cognition or response to treatment
Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
Lifetime history of ketamine or PCP abuse or dependence
ECT within three months
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
Pregnancy

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine

Methohexital

Arm Description

Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression-24 (HRSD24)

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.

Secondary Outcome Measures

Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)

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).

Full Information

NCT ID

NCT01309581

First Posted

March 2, 2011

Last Updated

July 29, 2013

Sponsor

James Murrough

1. Study Identification

Unique Protocol Identification Number

NCT01309581

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Terminated

Why Stopped

limited enrollment

Study Start Date

April 2010 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

James Murrough

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression, Bipolar Depression

Keywords

depression, electroconvulsive therapy, ketamine, antidepressant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine

Arm Type

Experimental

Arm Description

Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).

Arm Title

Methohexital

Arm Type

Active Comparator

Arm Description

Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

Ketamine 1-2 mg/kg IV as indicated for ECT

Intervention Type

Drug

Intervention Name(s)

Methohexital

Intervention Description

Methohexital 1 mg/kg IV as indicated for ECT

Primary Outcome Measure Information:

Title

Hamilton Rating Scale for Depression-24 (HRSD24)

Description

Time Frame

Change from beginning of ECT treatment to end; on average 3 weeks

Secondary Outcome Measure Information:

Title

Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)

Description

Time Frame

Change from beginning of ECT treatment to end; on average 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients: 18 to 59 years Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study DSM IV MINI diagnosis of major depressive episode (MDD), unipolar or bipolar Pretreatment 24-item Hamilton Rating Scale for Depression score > 21 ECT is clinically indicated Patient has the capacity to provide informed consent. Exclusion Criteria: DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or mental retardation Current primary diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression Current diagnosis of delirium, dementia, or amnestic disorder Baseline Mini Mental State Exam (MMSE) score < 24 and a total score falling two standard deviations below the age- and education-adjusted mean Any active general medical condition or CNS disease which can affect cognition or response to treatment Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week Lifetime history of ketamine or PCP abuse or dependence ECT within three months 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 Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James W Murrough, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York City

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mssm.edu/research/programs/mood-and-anxiety-disorders-program

Description

Mount Sinai School of Medicine Mood and Anxiety Disorders Program

Learn more about this trial

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

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