ClinicalTrials.gov

History of Changes for Study: NCT01309581
Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression
Latest version (submitted July 29, 2013) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 4, 2011 None (earliest Version on record)
2 December 30, 2011 Recruitment Status, Sponsor/Collaborators, Study Status, Study Identification, Contacts/Locations, Study Design and Study Description
3 July 29, 2013 Study Status, Results, Contacts/Locations, Outcome Measures and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT01309581
Submitted Date:  March 4, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: KETECT-MSSM-01
Brief Title: Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression
Official Title: Ketamine Anesthesia to Enhance Efficacy and Tolerability of Electroconvulsive Therapy in Patients With Unipolar or Bipolar Depression
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2011
Overall Status: Recruiting
Study Start: April 2010
Primary Completion: April 2013 [Anticipated]
Study Completion: April 2013 [Anticipated]
First Submitted: March 2, 2011
First Submitted that
Met QC Criteria:
March 4, 2011
First Posted: March 7, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 4, 2011
Last Update Posted: March 7, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Murrough, James, M.D.
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

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.

Detailed Description:
Open or close this module Conditions
Conditions: Major Depression
Bipolar Depression
Keywords: depression
electroconvulsive therapy
ketamine
antidepressant
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Outcomes Assessor)
Allocation: Randomized
Enrollment: 24 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. 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).
2. 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.
3. 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.
4. Autobiographical Memory Interview (AMI)
[ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ]

5. 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.
6. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Rosa Pasculli, BA
Telephone: 212-241-3089
Email: rosa.pasculli@mssm.edu
Study Officials: James W Murrough, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Locations: United States, New York
Mount Sinai Medical Center
[Recruiting]
New York City, New York, United States, 10029
Contact:Contact: James W Murrough, MD 212-241-7574 james.murrough@mssm.edu
Contact:Principal Investigator: James W Murrough, MD
Contact:Sub-Investigator: Charles H Kellner, MD
Contact:Sub-Investigator: David Reich, MD
Contact:Sub-Investigator: Andrew Perez, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Mount Sinai School of Medicine Mood and Anxiety Disorders Program
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services