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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01309581
Recruitment Status : Terminated (limited enrollment)
First Posted : March 7, 2011
Results First Posted : August 30, 2013
Last Update Posted : August 30, 2013
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE March 2, 2011
First Posted Date  ICMJE March 7, 2011
Results First Submitted Date  ICMJE November 7, 2012
Results First Posted Date  ICMJE August 30, 2013
Last Update Posted Date August 30, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2013)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2011)
  • 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).
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ]
    The BPRS is used to assess acute behavioral changes during the infusions. Four key BPRS items for the positive (+) symptoms of psychosis will be used: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content. Three items representing the negative (-) symptoms of psychosis will also be used: blunted affect, emotional withdrawal, and motor retardation.
  • Patient Rated Inventory of Side Effects (PRISE) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ]
    The PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other). Each system will score 0 to 2 based on the severity of the complaints (0 = no side effect, 1 = tolerable side effect, 2 = distressing side effect) and the total score is calculated.
  • Autobiographical Memory Interview (AMI) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ]
  • Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ]
    The CADSS is used to measure dissociative effects during the infusions. The scale includes 19 questions and 8 observer ratings scored from 0 (not at all) to 4 (extremely). The CADSS measures impairment in body perception, environmental perception, time perception, memory impairment, and feelings of unreality.
  • The Rey Auditory Verbal Learning Test (AVLT) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ]
    This scale is brief and easy to administer and has been well-validated. Equivalent alternate forms are available
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression
Official Title  ICMJE Ketamine Anesthesia to Enhance Efficacy and Tolerability of Electroconvulsive Therapy in Patients With Unipolar or Bipolar Depression
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depression
  • Bipolar Depression
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine 1-2 mg/kg IV as indicated for ECT
  • Drug: Methohexital
    Methohexital 1 mg/kg IV as indicated for ECT
Study Arms  ICMJE
  • Experimental: Ketamine
    Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
    Intervention: Drug: Ketamine
  • Active Comparator: Methohexital
    Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
    Intervention: Drug: Methohexital
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 29, 2013)
3
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2011)
24
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01309581
Other Study ID Numbers  ICMJE GCO 09-2251
KETECT-MSSM-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Murrough, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE James Murrough
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James W Murrough, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP