Status:
COMPLETED
The Effect on Cognition of Terminating ECT Induced Seizures With Propofol
Lead Sponsor:
Loma Linda University
Conditions:
Major Depression
Eligibility:
All Genders
45+ years
Phase:
NA
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 re...
Detailed Description
ECT Administration All patients will receive ECT administered using a Thymatron-System IV (Somatics, LLC , Lake Bluff, IL) ECT device, the same device used for our usual ECT. All patients will be moni...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00616759
Start Date
September 1 2006
End Date
March 24 2010
Last Update
June 8 2021
Active Locations (1)
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1
Loma Linda University
Loma Linda, California, United States, 92354