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The Effect on Cognition of Terminating ECT Induced Seizures With Propofol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald Warnell, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00616759
First received: February 4, 2008
Last updated: December 30, 2012
Last verified: December 2012
History of Changes
Results First Received: November 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depression
Interventions: Procedure: electroconvulsive therapy
Procedure: electroconvulsive therapy plus propofol
Drug: propofol

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Series of 6 ECTs Performed With Standard Technique Electroconvulsive Therapy (ECT) as usual
6 ECTs Where Seizure Was Shortened by Propofol ECT-induced seizures terminated with propofol

Participant Flow:   Overall Study
    Series of 6 ECTs Performed With Standard Technique     6 ECTs Where Seizure Was Shortened by Propofol  
STARTED     10     10  
COMPLETED     7     8  
NOT COMPLETED     3     2  
Physician Decision                 2                 0  
Withdrawal by Subject                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Series of 6 ECTs Performed With Standard Technique Electroconvulsive Therapy (ECT) as usual
6 ECTs Where Seizure Was Shortened by Propofol ECT-induced seizures terminated with propofol
Total Total of all reporting groups

Baseline Measures
    Series of 6 ECTs Performed With Standard Technique     6 ECTs Where Seizure Was Shortened by Propofol     Total  
Number of Participants  
[units: participants]
 		  10     10     20  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     9     9     18  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation 		  58.6  ± 7.3     57.1  ± 9.4     57.3  ± 8.22  
Gender  
[units: participants]
 		     
Female     6     5     11  
Male     4     5     9  
Region of Enrollment  
[units: participants]
 		     
United States     10     10     20  



  Outcome Measures

1.  Primary:   Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index   [ Time Frame: Pre-tesing within 36 hours before first ECT; Post-testing within 36 hours of 6th ECT. ]
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2.  Secondary:   California Verbal Learning Test (CVLT)   [ Time Frame: Within one week pre-ECT and within 48 hours after the 6th ECT ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


Limitations and Caveats
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
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Results Point of Contact:  
Name/Title: Ronald L. Warnell, M.D.
Organization: Loma Linda University
phone: 909-558-9551
e-mail: rwarnell@llu.edu


Publications of Results:


Responsible Party: Ronald Warnell, Loma Linda University
ClinicalTrials.gov Identifier: NCT00616759     History of Changes
Other Study ID Numbers: OSR#56164
Study First Received: February 4, 2008
Results First Received: November 30, 2010
Last Updated: December 30, 2012
Health Authority: United States: Institutional Review Board