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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
Sponsor:
Information provided by (Responsible Party):
Robin Wackernah, Porter Adventist Hospital

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).

Condition or disease Intervention/treatment Phase
Memory Impairment Drug: Donepezil Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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 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.
Drug: Placebo
Placebo capsule once daily 2 days before ECT and continuing through the last ECT procedure.
Other Name: Sucrose




Primary Outcome Measures :
  1. Columbia University Autobiographical Memory Interview-Short Form (AMI-SF) [ Time Frame: 4-5 weeks after first ECT treatment ]

Secondary Outcome Measures :
  1. Short Term Memory Four-Word MemoryTask [ Time Frame: 4-5 weeks after first ECT treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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United States, Colorado
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Sponsors and Collaborators
Porter Adventist Hospital
Investigators
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Principal Investigator: Robin Wackernah, Pharm.D. Pharmacist

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Responsible Party: Robin Wackernah, Pharmacist, Porter Adventist Hospital
ClinicalTrials.gov Identifier: NCT02331771     History of Changes
Other Study ID Numbers: PorterAH
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents