Trials / Terminated
TerminatedNCT02331771
Donepezil Memory Preservation Post ECT
Can Donepezil Preserve Autobiographical Memory Post Electroconvulsive Therapy? A Randomized, Placebo-Controlled Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Porter Adventist Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This randomized, placebo-controlled trial will evaluate the use of donepezil compared to placebo to reduce the risk of memory impairment after electroconvulsive therapy (ECT).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Donepezil | Donepezil 5 mg once daily 2 days before ECT and continuing through the last ECT procedure. |
| DRUG | Placebo | Placebo capsule once daily 2 days before ECT and continuing through the last ECT procedure. |
Timeline
- Start date
- 2015-09-24
- Primary completion
- 2017-01-25
- Completion
- 2017-03-24
- First posted
- 2015-01-06
- Last updated
- 2018-07-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02331771. Inclusion in this directory is not an endorsement.