Donepezil Memory Preservation Post ECT

NCT ID: NCT02331771

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-24
• Study Completion Date: 2017-03-24

Brief 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

Memory Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

donepezil

Subjects will receive donepezil 5 mg before before they start ECT and continue the agent through the ECT procedures up to 4 weeks.

Group Type: ACTIVE_COMPARATOR

Donepezil

Intervention Type: DRUG

Donepezil 5 mg once daily 2 days before ECT and continuing through the last ECT procedure.

Placebo

Subjects will receive the placebo before they start ECT and continue the agent through the ECT procedures up to 4 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule once daily 2 days before ECT and continuing through the last ECT procedure.

Interventions

Donepezil

Donepezil 5 mg once daily 2 days before ECT and continuing through the last ECT procedure.

Intervention Type: DRUG

Placebo

Placebo capsule once daily 2 days before ECT and continuing through the last ECT procedure.

Intervention Type: DRUG

Other Intervention Names

Aricept; Sucrose

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Porter Adventist Hospital

OTHER

Sponsor Role: lead

Responsible Party

Robin Wackernah

Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robin Wackernah, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Pharmacist

Locations

Porter Adventist Hospital

Denver, Colorado, United States

Countries

United States

Other Identifiers

PorterAH

Identifier Type: -

Identifier Source: org_study_id