The Effect on Cognition of Terminating ECT Induced Seizures With Propofol
This study has been completed.
Sponsor:
Loma Linda University
Information provided by (Responsible Party):
Ronald Warnell, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00616759
First received: February 4, 2008
Last updated: December 30, 2012
Last verified: December 2012
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Purpose
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 | Intervention |
|---|---|
|
Major Depression |
Procedure: electroconvulsive therapy Procedure: electroconvulsive therapy plus propofol Drug: propofol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect on Cognition of Terminating ECT Induced Seizures With Propofol |
Resource links provided by NLM:
Further study details as provided by Loma Linda University:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]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:
- California Verbal Learning Test (CVLT) [ Time Frame: Within one week pre-ECT and within 48 hours after the 6th ECT ] [ Designated as safety issue: No ]CVLT consists of a number of individual subtests of various aspects of memory. Higher scores indicate better memory function.
| Enrollment: | 20 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616759
Locations
| United States, California | |
| Loma Linda University | |
| Loma Linda, California, United States, 92354 | |
Sponsors and Collaborators
Loma Linda University
Investigators
| Principal Investigator: | Ronald L Warnell, MD | Loma Linda University |
More Information
Publications:
| Responsible Party: | Ronald Warnell, Principal Investigator, Loma Linda University |
| ClinicalTrials.gov Identifier: | NCT00616759 History of Changes |
| Other Study ID Numbers: | OSR#56164 |
| Study First Received: | February 4, 2008 |
| Results First Received: | November 30, 2010 |
| Last Updated: | December 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Loma Linda University:
|
Depression Electroconvulsive therapy |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Propofol Anesthetics, Intravenous |
Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on June 17, 2013