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The Effect on Cognition of Terminating ECT Induced Seizures With Propofol

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: NCT00616759
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : February 4, 2013
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Brief Summary:
Participating subjects are those who are referred for electroconvulsive therapy (ECT) for severe depression who have agreed to the protocol. The control group receives ECT as usual. The other group receives propofol to terminate the ECT-induced seizure timed so that the seizure lasts at least 25 seconds. Extensive neuropsychological testing is being done on both groups before beginning ECT and within 48 hours after the 6th treatment. Multiple markers of the rapidity of recovery from anesthesia are being obtained from all subjects for 6 ECTs.

Condition or disease Intervention/treatment Phase
Major Depression Procedure: electroconvulsive therapy Procedure: electroconvulsive therapy plus propofol Drug: propofol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect on Cognition of Terminating ECT Induced Seizures With Propofol
Study Start Date : September 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Propofol

Arm Intervention/treatment
Active Comparator: 1
ECT as usual
Procedure: electroconvulsive therapy
electroconvulsive therapy as usual

Experimental: 2
ECT-induced seizures terminated with propofol
Procedure: electroconvulsive therapy plus propofol
electroconvulsive therapy identical to the comparator group except that propofol 0.5 mg/kg is given intravenously 15 seconds after the electrical stimulation at each treatment in order to terminate the ECT-induced seizure
Other Name: Diprivan

Drug: propofol
Propofol 0.5 mg/kg intravenously given 15 seconds following electrical stimulation




Primary Outcome Measures :
  1. 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. ]
    WMS-III Auditory Delayed Index is a measure of memory functioning. The results given are the post-ECT testing results. A smaller number indicates less memory disturbance on this scale. The range of scores is between 0-140 with higher scores indicating better memory function.


Secondary Outcome Measures :
  1. California Verbal Learning Test (CVLT) [ Time Frame: Within one week pre-ECT and within 48 hours after the 6th ECT ]
    CVLT consists of a number of individual subtests of various aspects of memory. Higher scores indicate better memory function.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth edition, Text Revision (DSM-IV-TR) criteria for major depression, single episode or recurrent
  • Subjects must be over the age of 45 years
  • Subjects must be willing to receive at least six treatments of ECT, along with pre ECT lab screening and pre and post psychological and neuropsychological tests
  • The ability to read, speak and comprehend English and have the ability to complete the forms in writing
  • Must be able to give consent for treatment
  • Shorter acting benzodiazepines (aplrazolam, lorazepam) will be allowed on a prn basis but excluded 12 hours before each ECT session

Exclusion Criteria:

  • Subjects who have a history of schizophrenia, bipolar affective disorder, delusional disorder, paranoid disorder, or schizoaffective disorder, or who are exhibiting psychotic symptoms [except mood congruent depressive delusions].
  • Subjects who have a substance abuse/dependence disorder not in full remission
  • Patients with significant medical problems that may increase risk or require unusual concomitant treatment
  • Patients with significant neurological problems including seizure disorder
  • Patients with a hearing or visual impairment that would interfere with the research process
  • Patients with moderate to severe dementia. Any patient scoring less than 25 on the MMSE will have a Mattis Dementia Rating Scale-2 (DRS-2) test for dementia administered.
  • Patients known to be intolerant of propofol, etomidate, or succinylcholine, or for whom these anesthetic medications are not appropriate
  • Patients taking anticonvulsant medications such as Tegretol, Depakote, Klonopin, etc.
  • Patients on an involuntary admission status
  • Patients unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616759


Locations
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United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Ronald L Warnell, MD Loma Linda University

Publications of Results:
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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00616759    
Other Study ID Numbers: 56164
First Posted: February 15, 2008    Key Record Dates
Results First Posted: February 4, 2013
Last Update Posted: April 5, 2019
Last Verified: March 2019
Keywords provided by Loma Linda University:
Depression
Electroconvulsive therapy
Additional relevant MeSH terms:
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Seizures
Depression
Behavioral Symptoms
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics