Memory Functioning and Antidepressant Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296933
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : February 17, 2009
H. Lundbeck A/S
Information provided by:
University Health Network, Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Major Depressive Disorder Drug: Escitalopram Drug: Bupropion XL Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL
Study Start Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. General Verbal Memory-California Verbal Learning Test® -2nd ed (CVLT® -II)

Secondary Outcome Measures :
  1. Hamilton Rating Scale for Depression - 17-Item
  2. Clinical Global Impression Severity and Improvement Ratings
  3. Short Term & Working Memory: Wechsler Memory Scales III
  4. Nonverbal Memory - Faces
  5. WMS III Logical Memory (Prose Recall)
  6. Nonverbal Memory - Spatial Memory
  7. Shipley Institute of Living Scale
  8. Prospective Memory

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT00296933

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
H. Lundbeck A/S
Principal Investigator: Sidney H Kennedy, MD University Health Network, Toronto Identifier: NCT00296933     History of Changes
Other Study ID Numbers: UHN REB #05-0464-A
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors