The Effect on Cognition of Terminating ECT Induced Seizures With Propofol

Completed · Not applicable

Conditions studied: Major Depression

In brief

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.

Key facts

Study ID

NCT00616759

Run by

Loma Linda University

People needed

20

Starts

2006-09-01

Expected to finish

2010-03-24

Last updated by the study team

2021-06-08

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loma Linda University — Loma Linda, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.