Donepezil Memory Preservation Post ECT

Memory Impairment Clinical Trial

Official title:

Can Donepezil Preserve Autobiographical Memory Post Electroconvulsive Therapy? A Randomized, Placebo-Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02331771
• Other study ID #: PorterAH
• Status: Terminated
• Phase: N/A
• Start date: September 24, 2015
• Est. completion date: March 24, 2017

Study information

• Verified date: July 2018
• Source: Porter Adventist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 24, 2017
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of major depressive disorder, anxiety disorders, bipolar depression who are receiving right unilateral ECT will be included.

Exclusion Criteria:

• Patients with previous use of alcohol or illicit drugs within seven days of randomization will be excluded. Preexisting unstable cardiovascular disease including uncontrolled hypertension will be excluded. Patients with a documented allergy to donepezil will also be excluded. Patients with axis I disorders (eg. schizophrenia, schizoaffective disorder) other than major depressive disorder, anxiety disorders and/or bipolar depression will be excluded. Patients on anticoagulant therapy or chronic NSAID therapy will be excluded. Patients who are pregnant or wish to become pregnant within one year from trial enrollment will also be excluded. Patients who have received ECT within 6 months of enrollment will be excluded. Baseline Mini Mental State Examination (MMSE) < 24 will be excluded.

Related Conditions & MeSH terms

• Memory Impairment

Intervention

Drug:
• Donepezil
Donepezil 5 mg once daily 2 days before ECT and continuing through the last ECT procedure.
• Placebo
Placebo capsule once daily 2 days before ECT and continuing through the last ECT procedure.

Locations

Country	Name	City	State
United States	Porter Adventist Hospital	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Porter Adventist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)		4-5 weeks after first ECT treatment
Secondary	Short Term Memory Four-Word MemoryTask		4-5 weeks after first ECT treatment