Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression
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| ClinicalTrials.gov Identifier: NCT01309581 |
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Recruitment Status :
Terminated
(limited enrollment)
First Posted : March 7, 2011
Results First Posted : August 30, 2013
Last Update Posted : August 30, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depression Bipolar Depression | Drug: Ketamine Drug: Methohexital | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 3 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Ketamine Anesthesia to Enhance Efficacy and Tolerability of Electroconvulsive Therapy in Patients With Unipolar or Bipolar Depression |
| Study Start Date : | April 2010 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | October 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ketamine
Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
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Drug: Ketamine
Ketamine 1-2 mg/kg IV as indicated for ECT |
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Active Comparator: Methohexital
Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
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Drug: Methohexital
Methohexital 1 mg/kg IV as indicated for ECT |
- 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.
- 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).
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309581
| United States, New York | |
| Icahn School of Medicine at Mount Sinai | |
| New York City, New York, United States, 10029 | |
| Principal Investigator: | James W Murrough, MD | Icahn School of Medicine at Mount Sinai |
Additional Information:
| Responsible Party: | James Murrough, Principal Investigator, Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT01309581 History of Changes |
| Other Study ID Numbers: |
GCO 09-2251 KETECT-MSSM-01 |
| First Posted: | March 7, 2011 Key Record Dates |
| Results First Posted: | August 30, 2013 |
| Last Update Posted: | August 30, 2013 |
| Last Verified: | July 2013 |
Keywords provided by James Murrough, Icahn School of Medicine at Mount Sinai:
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depression electroconvulsive therapy ketamine antidepressant |
Additional relevant MeSH terms:
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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 |