The Effect on Cognition of Terminating ECT Induced Seizures With Propofol

NCT00616759 | Completed Results

• 1 other identifier: 56164
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depression

Keywords

Depression; Electroconvulsive therapy

Outcome Measures

Primary Outcomes (1)

• Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index

  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.

  Pre-tesing within 36 hours before first ECT; Post-testing within 36 hours of 6th ECT.

Study Arms (2)

1

ACTIVE COMPARATOR

ECT as usual

Procedure: electroconvulsive therapy

2

EXPERIMENTAL

ECT-induced seizures terminated with propofol

Procedure: electroconvulsive therapy plus propofol; Drug: propofol

Interventions

electroconvulsive therapy PROCEDURE

electroconvulsive therapy as usual

1

electroconvulsive therapy plus propofol PROCEDURE

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

Also known as: Diprivan

2

propofol DRUG

Propofol 0.5 mg/kg intravenously given 15 seconds following electrical stimulation

2

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Related Publications (1)

• Warnell RL, Swartz CM, Thomson A. Propofol interruption of ECT seizure to reduce side-effects: a pilot study. Psychiatry Res. 2010 Jan 30;175(1-2):184-5. doi: 10.1016/j.psychres.2009.08.019. Epub 2009 Nov 5.

  PMID: 19892408 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Electroconvulsive Therapy; Propofol

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Ronald L. Warnell, M.D.
• Organization: Loma Linda University

rwarnell@llu.edu

909-558-9551

Study Officials

• Ronald L Warnell, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: September 1, 2006
• Primary Completion: March 24, 2010
• Study Completion: March 24, 2010
• Last Updated: June 8, 2021
• Results First Posted: February 4, 2013

Record last verified: 2021-05

Locations

US (1)