DepressionPhase 3NCT00296933
Memory Functioning and Antidepressant Treatment
A Phase 3 study testing Escitalopram and Bupropion XL in people with Depression and Major Depressive Disorder, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- Escitalopram and Bupropion XL
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL
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.
Read the 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:
- Which subtypes of memory at baseline are more impaired?
- What is the relationship between memory impairment and symptom severity and previous number of episodes or duration of illness?
- Is successful AD treatment associated with improvement in memory functioning?
- Is there a main effect by AD type?
- On which subtypes of memory do patients improve, worsen, or remain neutral in the 2 different AD groups? (Main effect of memory type?)
- 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.
- Conditions
- Depression, Major Depressive Disorder
- Being tested
- Escitalopram, Bupropion XL
- Keywords
- Major Depression, Antidepressant, Pharmacotherapy, Memory functioning, Memory Impairment
- Medical subject headings
- Depression, Depressive Disorder, Major, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Bupropion XLDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
General Verbal Memory-California Verbal Learning Test® -2nd ed (CVLT® -II)
Secondary outcomes (8)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, H. Lundbeck A/S
- Investigators
- Sidney H Kennedy, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296933
- Sponsor's protocol ID
- UHN REB #05-0464-A
- Status last verified
- Feb 2009
- First submitted
- 23 Feb 2006
- Last updated
- 17 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL
- ClinicalTrials.gov ID
- NCT00296933
- Acronym / sponsor ID
- UHN REB #05-0464-A
- Conditions
- Depression, Major Depressive Disorder
- Keywords
- Major Depression, Antidepressant, Pharmacotherapy, Memory functioning, Memory Impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, H. Lundbeck A/S
- Study start
- Dec 2005
- First posted
- 27 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Which subtypes of memory at baseline are more impaired?
- What is the relationship between memory impairment and symptom severity and previous number of episodes or duration of illness?
- Is successful AD treatment associated with improvement in memory functioning?
- Is there a main effect by AD type?
- On which subtypes of memory do patients improve, worsen, or remain neutral in the 2 different AD groups? (Main effect of memory type?)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram | Drug | – |
| Bupropion XL | Drug | – |
Primary outcome
General Verbal Memory-California Verbal Learning Test® -2nd ed (CVLT® -II)
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidney H Kennedy, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Escitalopram and Bupropion XL in people with Depression and Major Depressive Disorder, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Verbal Memory-California Verbal Learning Test® -2nd ed (CVLT® -II). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2009.