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

This study has been terminated.
(limited enrollment)
Sponsor:
Information provided by (Responsible Party):
James Murrough, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01309581
First received: March 2, 2011
Last updated: July 29, 2013
Last verified: July 2013
Results First Received: November 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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


No publications provided


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
Study First Received: March 2, 2011
Results First Received: November 7, 2012
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board