Memory Functioning and Antidepressant Treatment

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
H. Lundbeck A/S
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00296933
First received: February 23, 2006
Last updated: February 16, 2009
Last verified: February 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Bupropion
Antidepressive Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Psychotropic Drugs
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014