Donepezil Memory Preservation Post ECT

NCT02331771 | Terminated

• 1 other identifier: PorterAH
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Memory Impairment

Outcome Measures

Primary Outcomes (1)

• Columbia University Autobiographical Memory Interview-Short Form (AMI-SF)

  4-5 weeks after first ECT treatment

Secondary Outcomes (1)

• Short Term Memory Four-Word MemoryTask

  4-5 weeks after first ECT treatment

Study Arms (2)

donepezil

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Donepezil DRUG

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

Also known as: Aricept

donepezil

Placebo DRUG

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

Also known as: Sucrose

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Porter Adventist Hospital: lead

Study Sites (1)

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

MeSH Terms

Conditions

Memory Disorders

Interventions

Donepezil; Sucrose

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Robin Wackernah, Pharm.D.

  Pharmacist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 6, 2015
• Study Start: September 24, 2015
• Primary Completion: January 25, 2017
• Study Completion: March 24, 2017
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

US (1)