Depression Clinical Trial
Official title:
Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL
Verified date | February 2009 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | GlaxoSmithKline, H. Lundbeck A/S |
Canada,
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 |
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