Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00296933
Status:
COMPLETED
Last Update Posted:
2009-02-17
First Post:
2006-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Memory Functioning and Antidepressant Treatment
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: