Donepezil Memory Preservation Post ECT

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

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).

Study Overview

• Status: Terminated
• Conditions: Memory Impairment
• Intervention / Treatment: Drug: Donepezil; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80210
      • Porter Adventist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Donepezil; Donepezil 5 mg once daily 2 days before ECT and continuing through the last ECT procedure.; Other Names: 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.	Drug: Placebo; Placebo capsule once daily 2 days before ECT and continuing through the last ECT procedure.; Other Names: Sucrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)	4-5 weeks after first ECT treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Short Term Memory Four-Word MemoryTask	4-5 weeks after first ECT treatment

Collaborators and Investigators

• Sponsor: Porter Adventist Hospital
• Investigators: Principal Investigator: Robin Wackernah, Pharm.D., pharmacist

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2015
• Primary Completion (Actual): January 25, 2017
• Study Completion (Actual): March 24, 2017

Study Registration Dates

• First Submitted: December 31, 2014
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: PorterAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No