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

This study has been terminated.
(limited enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309581
First Posted: March 7, 2011
Last Update Posted: August 30, 2013
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.
Information provided by (Responsible Party):
James Murrough, Mount Sinai School of Medicine
Results First Submitted: November 7, 2012  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ketamine Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Methohexital Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).

Participant Flow:   Overall Study
    Ketamine   Methohexital
STARTED   2   1 
COMPLETED   2   1 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ketamine Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Methohexital Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Total Total of all reporting groups

Baseline Measures
   Ketamine   Methohexital   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   1   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 53  (5.6)   50  (0)   50  (4.3) 
Gender 
[Units: Participants]
     
Female   2   1   3 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   2   1   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton Rating Scale for Depression-24 (HRSD24)   [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ]

2.  Secondary:   Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)   [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination, limited enrollment, data analysis not done due to technical problems with measurement leading to unreliable and uninterpretable data.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: James Murrough
Organization: Mount Sinai School of Medicine
phone: 212 241 7574
e-mail: James.Murrough@mssm.edu



Responsible Party: James Murrough, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01309581     History of Changes
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