Memory Functioning and Antidepressant Treatment - Full Text View

Sponsor:	University Health Network, Toronto
Collaborators:	GlaxoSmithKline H. Lundbeck A/S
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00296933

Purpose

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.

Condition	Intervention	Phase
Depression Major Depressive Disorder	Drug: Escitalopram Drug: Bupropion XL	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Memory

Drug Information available for: Benzetimide Dexetimide Bupropion hydrochloride Bupropion Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296933

Locations

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

Sponsors and Collaborators

University Health Network, Toronto

GlaxoSmithKline

H. Lundbeck A/S

Investigators

Principal Investigator:

Sidney H Kennedy, MD

University Health Network, Toronto

More Information

No publications provided

Study ID Numbers:	UHN REB #05-0464-A
Study First Received:	February 23, 2006
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00296933 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Major Depression
Antidepressant
Pharmacotherapy
Memory functioning
Memory Impairment

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation

Dexetimide
Antidepressive Agents
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Bupropion
Mood Disorders
Dopamine Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009