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Memory Functioning and Antidepressant Treatment
This study is currently recruiting participants.
Verified by University Health Network, Toronto, January 2006
Sponsors and Collaborators: University Health Network, Toronto
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

MedlinePlus related topics: Antidepressants Depression Memory
Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Bupropion hydrochloride Bupropion
U.S. FDA Resources
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

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:

  1. Which subtypes of memory at baseline are more impaired?
  2. What is the relationship between memory impairment and symptom severity and previous number of episodes or duration of illness?
  3. Is successful AD treatment associated with improvement in memory functioning?
  4. Is there a main effect by AD type?
  5. On which subtypes of memory do patients improve, worsen, or remain neutral in the 2 different AD groups? (Main effect of memory type?)
  6. 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

Contacts
Contact: Sidney H Kennedy, MD 416-340-3888 sidney.kennedy@uhn.on.ca
Contact: Beverley B Bouffard, MA 416-340-4800 ext 3739 beverley.bouffard@uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Principal Investigator: Sidney H Kennedy, MD            
Sub-Investigator: Rima G Styra, MD            
Sub-Investigator: Roger S McIntyre, MD            
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

Study ID Numbers: UHN REB #05-0464-A
Study First Received: February 23, 2006
Last Updated: October 18, 2006
ClinicalTrials.gov Identifier: NCT00296933  
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Major Depression
Antidepressant
Pharmacotherapy
Memory functioning
Memory Impairment

Study placed in the following topic categories:
Dopamine
Depression
Mental Disorders
Bupropion
Mood Disorders
Depressive Disorder, Major
Dexetimide
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009