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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Major Depression
Bipolar Depression
Interventions Drug: Ketamine
Drug: Methohexital
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Methohexital
Hide Arm/Group Description Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic). Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Period Title: Overall Study
Started 2 1
Completed 2 1
Not Completed 0 0
Arm/Group Title Ketamine Methohexital Total
Hide Arm/Group Description Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic). Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic). Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 3 participants
53  (5.6) 50  (0) 50  (4.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
2
 100.0%
1
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Hamilton Rating Scale for Depression-24 (HRSD24)
Hide Description 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.
Time Frame Change from beginning of ECT treatment to end; on average 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Methohexital
Hide Arm/Group Description:
Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)
Hide Description 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).
Time Frame Change from beginning of ECT treatment to end; on average 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Methohexital
Hide Arm/Group Description:
Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Methohexitol
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Ketamine Methohexitol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ketamine Methohexitol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Methohexitol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      1/1 (100.00%)    
Cardiac disorders     
Dizziness on standing †  1/2 (50.00%)  1 0/1 (0.00%)  0
Gastrointestinal disorders     
Constipation †  0/2 (0.00%)  0 1/1 (100.00%)  1
Dry mouth †  1/2 (50.00%)  1 0/1 (0.00%)  0
Nervous system disorders     
Headache †  1/2 (50.00%)  1 0/1 (0.00%)  0
Sleep disturbance †  1/2 (50.00%)  1 0/1 (0.00%)  0
Restlessness †  0/2 (0.00%)  0 1/1 (100.00%)  1
Renal and urinary disorders     
Frequent Urination †  1/2 (50.00%)  1 0/1 (0.00%)  0
†
Indicates events were collected by systematic assessment
Early termination, limited enrollment, data analysis not done due to technical problems with measurement leading to unreliable and uninterpretable data.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Murrough
Organization: Mount Sinai School of Medicine
Phone: 212 241 7574
EMail: James.Murrough@mssm.edu
Layout table for additonal information
Responsible Party: James Murrough, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01309581    
Other Study ID Numbers: GCO 09-2251
KETECT-MSSM-01
First Submitted: March 2, 2011
First Posted: March 7, 2011
Results First Submitted: November 7, 2012
Results First Posted: August 30, 2013
Last Update Posted: August 30, 2013