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The Effect on Cognition of Terminating ECT Induced Seizures With Propofol
This study is ongoing, but not recruiting participants.
Sponsored by: Loma Linda University
Information provided by: Loma Linda University
ClinicalTrials.gov Identifier: NCT00616759
  Purpose

Participating subjects are those who are referred for electroconvulsive therapy 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
Drug: propofol

Genetics Home Reference related topics: pyridoxine-dependent epilepsy
MedlinePlus related topics: Depression Seizures
Drug Information available for: Propofol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment
Official Title: The Effect on Cognition of Terminating ECT Induced Seizures With Propofol

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Wechsler Memory Scale-III [ Time Frame: Within one week Pre-ECT and within 48 hours after the 6th ECT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • California Verbal Learning Test [ Time Frame: Within one week pre-ECT and within 48 hours after the 6th ECT ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
ECT as usual
Procedure: electroconvulsive therapy
electroconvulsive therapy as usual
2: Experimental
ECT-induced seizures terminated with propofol
Drug: propofol
electroconvulsive therapy plus propofol

  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 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 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

Responsible Party: Loma Linda Universtiy ( Ronald L. Warnell, M.D. )
Study ID Numbers: OSR#56164
Study First Received: February 4, 2008
Last Updated: August 26, 2008
ClinicalTrials.gov Identifier: NCT00616759  
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Depression
Electroconvulsive therapy

Study placed in the following topic categories:
Depression
Mental Disorders
Seizures
Mood Disorders
Depressive Disorder, Major
Propofol
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009