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N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression

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ClinicalTrials.gov Identifier: NCT01260649
Recruitment Status : Terminated (lack of funding to cover staff salary (clinician and research coordinator))
First Posted : December 15, 2010
Results First Posted : April 14, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: ketamine
Other: IV Saline
Procedure: ECT
Drug: Muscle Relaxant
Drug: Anesthetic Agents
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description

ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.

Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

Period Title: Overall Study
Started 8 9
Completed 6 8
Not Completed 2 1
Arm/Group Title Ketamine Placebo Total
Hide Arm/Group Description

ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.

Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

Total of all reporting groups
Overall Number of Baseline Participants 6 8 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
7
  87.5%
13
  92.9%
>=65 years
0
   0.0%
1
  12.5%
1
   7.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 8 participants 14 participants
41.43  (15.62) 48.75  (12.22) 48.57  (13.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
Female
4
  66.7%
7
  87.5%
11
  78.6%
Male
2
  33.3%
1
  12.5%
3
  21.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 8 participants 14 participants
6 8 14
1.Primary Outcome
Title Change in Hamilton Depression Rating Scale - 28
Hide Description

HAMD will be administered at every ECT treatment.The HAM D 28 is a 28 item scale with scores ranging from 0 to 83, with 0 being no depression and 83 being high levels of depression symptoms.

The change in HAM S score was determined by the difference of the HAM D score at the last ECT administration and the baseline HAM D score. A negative change score reflects a decreased HAM D score between the first and last ECT administration and therefore a reduction in depressive symptoms.

Time Frame baseline, one month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.

Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

Overall Number of Participants Analyzed 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-17.50  (6.53) -14.00  (14.20)
2.Secondary Outcome
Title Number of Participants With Cognitive Side Effects
Hide Description will compare the incidence of participants with memory deficits between groups, as determined by incidents of clinician reported cognitive adverse events
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.

Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

Overall Number of Participants Analyzed 6 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  12.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description

ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.

Right unilateral ECT at 5-6x seizure threshold three times a week

ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care

All-Cause Mortality
Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      1/8 (12.50%)    
Musculoskeletal and connective tissue disorders     
Body pain   0/6 (0.00%)  0 1/8 (12.50%)  1
Psychiatric disorders     
Racing Thoughts   0/6 (0.00%)  0 1/8 (12.50%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      3/8 (37.50%)    
Cardiac disorders     
Heart pounding/tightness in chest   1/6 (16.67%)  1 0/8 (0.00%)  0
Ear and labyrinth disorders     
Fluid in right ear   0/6 (0.00%)  0 1/8 (12.50%)  1
General disorders     
Fatigue   0/6 (0.00%)  0 1/8 (12.50%)  1
Hepatobiliary disorders     
Increased Blood sugar   0/6 (0.00%)  0 1/8 (12.50%)  1
Musculoskeletal and connective tissue disorders     
Jaw pain   1/6 (16.67%)  1 0/8 (0.00%)  0
Nervous system disorders     
Short term memory impairment   0/6 (0.00%)  0 1/8 (12.50%)  1
Dizziness   0/6 (0.00%)  0 1/8 (12.50%)  1
Numbness in feet and body   1/6 (16.67%)  1 0/8 (0.00%)  0
Tingling in feet   1/6 (16.67%)  1 0/8 (0.00%)  0
Psychiatric disorders     
Sedation   0/6 (0.00%)  0 1/8 (12.50%)  1
Agitation   0/6 (0.00%)  0 1/8 (12.50%)  2
Anxiety   1/6 (16.67%)  1 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Cristina Cusin
Organization: MGH
Phone: 617 726 64221
Responsible Party: Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01260649     History of Changes
Other Study ID Numbers: 2010P001672
First Submitted: December 7, 2010
First Posted: December 15, 2010
Results First Submitted: March 3, 2017
Results First Posted: April 14, 2017
Last Update Posted: May 22, 2017