Donepezil Memory Preservation Post ECT
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|ClinicalTrials.gov Identifier: NCT02331771|
Recruitment Status : Terminated (Lack of sufficient enrollment)
First Posted : January 6, 2015
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Memory Impairment||Drug: Donepezil Drug: Placebo||Not Applicable|
Electroconvulsive therapy (ECT) is a method used to treat a variety of psychiatric conditions. An electrical current is distributed throughout the brain (Lisanby 2007) inducing seizure activity in a controlled setting using neuromuscular blocking agents (Mirzakhani 2012) while the patient is under anesthesia (Deiner 2009). ECT is approved by the Food and Drug Administration (FDA) for the following conditions: unipolar and bipolar depression, manic and mixed states in bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder and catatonia (FDA executive summary). ECT is often used after trials of psychotropic medications have failed (Kellner 2012).
Electroconvulsive therapy (ECT) is commonly associated with cognitive side effects that range from anterograde and retrograde amnesia to issues with executive function, attention and declines in information processing. Problems with autobiographical memory and recall for new information appear to be affected the most. In addition, data suggests that the loss of memory of autobiographical events may persist as long as six months. These issues may cause patient adherence problems and potential relapses into previous psychiatric conditions.
Donepezil is an acetylcholinesterase inhibitor indicated for Alzheimer's Dementia and has been shown to slow the progressive decline in cognition and memory in Alzheimer's Dementia. It is hypothesized that donepezil will help to preserve memory and minimize the decline in memory that is associated with the administration of ECT.
This study aims to determine if donepezil can minimize deficiencies in autobiographical memory 4-5 weeks after ECT treatment has been started.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Can Donepezil Preserve Autobiographical Memory Post Electroconvulsive Therapy? A Randomized, Placebo-Controlled Trial|
|Actual Study Start Date :||September 24, 2015|
|Actual Primary Completion Date :||January 25, 2017|
|Actual Study Completion Date :||March 24, 2017|
Active Comparator: donepezil
Subjects will receive donepezil 5 mg before before they start ECT and continue the agent through the ECT procedures up to 4 weeks.
Donepezil 5 mg once daily 2 days before ECT and continuing through the last ECT procedure.
Other Name: Aricept
Placebo Comparator: Placebo
Subjects will receive the placebo before they start ECT and continue the agent through the ECT procedures up to 4 weeks.
Placebo capsule once daily 2 days before ECT and continuing through the last ECT procedure.
Other Name: Sucrose
- Columbia University Autobiographical Memory Interview-Short Form (AMI-SF) [ Time Frame: 4-5 weeks after first ECT treatment ]
- Short Term Memory Four-Word MemoryTask [ Time Frame: 4-5 weeks after first ECT treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331771
|United States, Colorado|
|Porter Adventist Hospital|
|Denver, Colorado, United States, 80210|
|Principal Investigator:||Robin Wackernah, Pharm.D.||Pharmacist|