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Sponsored by: |
Loma Linda University |
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Information provided by: | Loma Linda University |
ClinicalTrials.gov Identifier: | NCT00616759 |
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 |
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Major Depression |
Procedure: electroconvulsive therapy Drug: propofol |
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 |
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 |
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1: Active Comparator
ECT as usual
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Procedure: electroconvulsive therapy
electroconvulsive therapy as usual
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2: Experimental
ECT-induced seizures terminated with propofol
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Drug: propofol
electroconvulsive therapy plus propofol
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Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Loma Linda University | |
Loma Linda, California, United States, 92354 |
Principal Investigator: | Ronald L Warnell, MD | Loma Linda University |
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 |
Depression Electroconvulsive therapy |
Depression Mental Disorders Seizures Mood Disorders |
Depressive Disorder, Major Propofol Depressive Disorder Behavioral Symptoms |
Anesthetics, Intravenous Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Physiological Effects of Drugs |
Central Nervous System Depressants Anesthetics Central Nervous System Agents Pharmacologic Actions |