Overview

The Effect on Cognition of Terminating ECT Induced Seizures With Propofol

Status:
Completed
Trial end date:
2010-03-24
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Loma Linda University
Treatments:
Propofol
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