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Sponsors and Collaborators: |
University Health Network, Toronto GlaxoSmithKline H. Lundbeck A/S |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00296933 |
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 |
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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 |
Estimated Enrollment: | 60 |
Study Start Date: | December 2005 |
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:
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Sidney H Kennedy, MD | University Health Network, Toronto |
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 |
Major Depression Antidepressant Pharmacotherapy Memory functioning Memory Impairment |
Dopamine Depression Mental Disorders Bupropion Mood Disorders Depressive Disorder, Major |
Dexetimide Depressive Disorder Citalopram Serotonin Behavioral Symptoms |
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 |