The Effect on Cognition of Terminating ECT Induced Seizures With Propofol

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mental Disorders
Mood Disorders
Propofol
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014