Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression - Full Text View

Purpose

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.

Condition	Intervention
Major Depression Bipolar Depression	Drug: Ketamine Drug: Methohexital


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Ketamine Anesthesia to Enhance Efficacy and Tolerability of Electroconvulsive Therapy in Patients With Unipolar or Bipolar Depression

Resource links provided by NLM:

Drug Information available for: Methohexital sodium Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:

Hamilton Rating Scale for Depression-24 (HRSD24) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: No ]
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).


Enrollment:	3
Study Start Date:	April 2010
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309581

Locations


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

Sponsors and Collaborators

James Murrough

Investigators


Principal Investigator:	James W Murrough, MD	Icahn School of Medicine at Mount Sinai

More Information

Additional Information:

Mount Sinai School of Medicine Mood and Anxiety Disorders Program This link exits the ClinicalTrials.gov site


Responsible Party:	James Murrough, Principal Investigator, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT01309581 History of Changes
Other Study ID Numbers:	GCO 09-2251 KETECT-MSSM-01
Study First Received:	March 2, 2011
Results First Received:	November 7, 2012
Last Updated:	July 29, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Icahn School of Medicine at Mount Sinai:


depression electroconvulsive therapy ketamine antidepressant

Additional relevant MeSH terms:


Depression Depressive Disorder Depressive Disorder, Major Bipolar Disorder Behavioral Symptoms Mood Disorders Mental Disorders Bipolar and Related Disorders Ketamine Methohexital Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016