Memory Functioning and Antidepressant Treatment

Depression Clinical Trial

Official title:

Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296933
• Other study ID #: UHN REB #05-0464-A
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2006
• Last updated: February 16, 2009
• Start date: December 2005

Study information

• Verified date: February 2009
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram

• Bupropion XL

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	GlaxoSmithKline, H. Lundbeck A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Verbal Memory-California Verbal Learning Test® -2nd ed (CVLT® -II)
Secondary	Hamilton Rating Scale for Depression - 17-Item
Secondary	Clinical Global Impression Severity and Improvement Ratings
Secondary	Short Term & Working Memory: Wechsler Memory Scales III
Secondary	Nonverbal Memory - Faces
Secondary	WMS III Logical Memory (Prose Recall)
Secondary	Nonverbal Memory - Spatial Memory
Secondary	Shipley Institute of Living Scale
Secondary	Prospective Memory