Memory Functioning and Antidepressant Treatment

NCT00296933 | Completed Phase 3

• 1 other identifier: UHN REB #05-0464-A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Major Depressive Disorder

Keywords

Major Depression; Antidepressant; Pharmacotherapy; Memory functioning; Memory Impairment

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

Escitalopram DRUG

Bupropion XL DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• GlaxoSmithKline: collaborator
• H. Lundbeck A/S: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Memory Disorders

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sidney H Kennedy, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 27, 2006
• Study Start: December 1, 2005
• Last Updated: February 17, 2009

Record last verified: 2009-02

Locations

CA (1)