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

NCT ID: NCT01309581

Last Updated: 2013-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-10-31

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.

Conditions

Major Depression; Bipolar Depression

Keywords

depression; electroconvulsive therapy; ketamine; antidepressant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ketamine

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Methohexital

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

Group Type: ACTIVE_COMPARATOR

Methohexital

Intervention Type: DRUG

Methohexital 1 mg/kg IV as indicated for ECT

Interventions

Ketamine

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

Intervention Type: DRUG

Methohexital

Methohexital 1 mg/kg IV as indicated for ECT

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Murrough

OTHER

Sponsor Role: lead

Responsible Party

James Murrough

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James W Murrough, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

KETECT-MSSM-01

Identifier Type: -

Identifier Source: secondary_id

GCO 09-2251

Identifier Type: -

Identifier Source: org_study_id