Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Bipolar Depression
Intervention: Ketamine (Drug); Methohexital (Drug)
Phase: N/A
Status: Terminated
Sponsored by: James Murrough Official(s) and/or principal investigator(s): James W Murrough, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
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.
Clinical Details
Official title: Ketamine Anesthesia to Enhance Efficacy and Tolerability of Electroconvulsive Therapy in Patients With Unipolar or Bipolar Depression
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Hamilton Rating Scale for Depression-24 (HRSD24)
Secondary outcome: Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Icahn School of Medicine at Mount Sinai, New York City, New York 10029, United States
Additional Information
Mount Sinai School of Medicine Mood and Anxiety Disorders Program
Starting date: April 2010
Last updated: July 29, 2013
|