Memory Functioning and Antidepressant Treatment

February 16, 2009 updated by: University Health Network, Toronto

Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL

Major Depressive Disorder (MDD) is a serious illness associated with considerable morbidity, risk of suicide and adverse social consequences (Montgomery et al., 1994a). Cognitive impairment is one of the three major symptom areas of MDD. Specifically, memory impairment and concerns are one of the most commonly reported complaints in MDD. While antidepressant (AD) treatments vary a great deal in their propensity to cause cognitive impairment, there remains a paucity of empirical evidence on the effects of AD treatment on neuropsychological indices of memory functioning in non-geriatric depressed individuals. Hence, comparative effects of various AD drugs on memory functioning remain unclear.The aim of this study is to evaluate multiple aspects of memory functioning (short-term, working memory, verbal, non-verbal, spatial and prospective memory) of MDD patients before and after 8 weeks of antidepressant treatment with bupropion XL or escitalopram.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose of the Present Study:

The purpose of the present study is to comprehensively evaluate memory functioning of MDD patients before and after 8 weeks of antidepressant treatment with bupropion-XL or escitalopram. A neuropsychological test battery will incorporate multiple aspects of memory functioning including: short-term & working memory; verbal, non-verbal, spatial and prospective memory.

Major Research Questions:

Which subtypes of memory at baseline are more impaired?
What is the relationship between memory impairment and symptom severity and previous number of episodes or duration of illness?
Is successful AD treatment associated with improvement in memory functioning?
Is there a main effect by AD type?
On which subtypes of memory do patients improve, worsen, or remain neutral in the 2 different AD groups? (Main effect of memory type?)
What is the relationship between change in memory function and symptomatic outcome?

Study Design:

This is a randomized, double-blind, double-dummy trial comparing the memory functioning of depressed subjects before and after 8 weeks of treatment with bupropion-XL as compared to escitalopram.

All consenting, eligible subjects will receive either active bupropion-XL or active escitalopram following the baseline visit. Doses will be fixed with an opportunity for dose reduction if subjects are unable to tolerate fixed dose.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 2C4
    - University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Males and Females
Age: 18-50
Recurrent Major Depressive Disorder; current Major Depressive Episode with at least one prior episode
HAM-D >16
Able to give written informed consent
Agree to use a reliable means of birth control during the study, as determined by the investigator (females of child-bearing potential only)

Exclusion Criteria:

History of head injury or loss of consciousness for longer than 30 minutes
Presence of primary anxiety disorder, bipolar I or II disorder, or psychotic disorders
Presence of anorexia nervosa or bulimia nervosa
Presence or history of epilepsy or other seizure disorders
Presence of significant Axis II disorder based on investigator judgment
Presence of significant unstable medical condition
Presence or past history of ADHD or significant learning disability
ECTs (unilateral) within the past 12 months or bilateral ECT (ever)
More than 2 failed adequate antidepressant treatments in the current episode
Pregnant or breast-feeding females
Have received treatment within the last 30 days with an investigational drug
Prior non-response to either bupropion-XL or escitalopram
Current treatment with Zyban (bupropion hydrochloride)
Antidepressant treatment within the last week (within the last 3 weeks fluoxetine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
General Verbal Memory-California Verbal Learning Test® -2nd ed (CVLT® -II)

Secondary Outcome Measures

Outcome Measure
Hamilton Rating Scale for Depression - 17-Item
Clinical Global Impression Severity and Improvement Ratings
Short Term & Working Memory: Wechsler Memory Scales III
Nonverbal Memory - Faces
WMS III Logical Memory (Prose Recall)
Nonverbal Memory - Spatial Memory
Shipley Institute of Living Scale
Prospective Memory

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

GlaxoSmithKline

H. Lundbeck A/S

Investigators

Principal Investigator: Sidney H Kennedy, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

February 17, 2009

Last Update Submitted That Met QC Criteria

February 16, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

UHN REB #05-0464-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.