N/A
N=20
The Effect on Cognition of Terminating ECT Induced Seizures With Propofol
Major Depression
Bottom Line
View on ClinicalTrials.gov: NCT00616759 ↗Enrolled (actual)
20
Serious AEs
—
Results posted
Feb 2013
Primary outcome: Primary: Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- electroconvulsive therapy (Procedure); electroconvulsive therapy plus propofol (Procedure); propofol (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00616759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.