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Trial record 37 of 89 for:    DESVENLAFAXINE

Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01468610
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : April 10, 2015
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
This study will investigate the relationships between subjective cognitive complaints, neurocognitive deficits, and work productivity in participants with Major Depressive Disorder (MDD), before and after 8 weeks of treatment with an antidepressant medication. Our hypothesis is that, in working participants with MDD of at least moderate severity, neurocognitive deficits will predict poorer work functioning and productivity.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: desvenlafaxine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurocognition and Work Productivity in Major Depressive Disorder
Study Start Date : January 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Workers with MDD Drug: desvenlafaxine
50-100 mg daily for 8 weeks
Other Name: Pristiq

Primary Outcome Measures :
  1. cognitive functioning as determined by neuropsychological testing [ Time Frame: change from baseline to 8 weeks ]
    Neuropsychological testing in 5 domains (memory, psychomotor speed, reaction time, cognitive flexibility, and complex attention) is conducted using computerized measures, both at baseline and after 8 weeks of standard medical care involving antidepressant medication (flexibly-dosed desvenlafaxine)

Secondary Outcome Measures :
  1. work productivity as determined by rating scales [ Time Frame: change from baseline to 8 weeks ]
    Work functioning (attendance and productivity) is assessed using subjective and objective measures, both at baseline and after 8 weeks of standard medical care involving antidepressant medication (flexibly-dosed desvenlafaxine)

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Clinical diagnosis of Major Depressive Disorder as per DSM-IV-TR
  2. Current employment of at least 15 hours per week
  3. Baseline score of 23 or greater on the Montgomery-Asberg Depression Rating Scale, indicating at least moderately severe depression
  4. Baseline score of 6 or greater on the British Columbia Cognitive Complaints Inventory, indicating at least moderate subjective cognitive complaints
  5. Competency to give informed consent

Exclusion Criteria:

  1. Current receipt of short-term or long-term disability benefits from employer
  2. Serious suicidal risks as judged by the investigators
  3. Other DSM-IV-TR diagnoses:

    1. organic mental disorders
    2. active substance abuse/dependence, including alcohol
    3. schizophrenia, paranoid or delusional disorders, or other psychotic disorders
    4. (as primary diagnosis:) panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder
    5. bipolar disorder
    6. bulimia nervosa or anorexia nervosa
  4. Serious illness that is not stabilized, including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease
  5. Regular/current use of other psychotropic drugs and/or herbaceuticals
  6. Use of fluoxetine within 5 weeks of Visit 1, monoamine oxidase inhibitors within 14 days of Visit 1, and other antidepressants within 7 days of Visit 1 (all to ensure adequate drug washouts prior to neurocognitive assessment)
  7. Previous treatment with desvenlafaxine
  8. Treatment-resistance in the current episode, as defined by failure (i.e., lack of clinically significant response) of 2 or more antidepressants given at therapeutic doses for at least 6 weeks
  9. Any history of treatment with electroconvulsive therapy
  10. Initiation of formal psychotherapy (e.g., cognitive-behavioural therapy or interpersonal psychotherapy) with 2 months of Visit 1, or plans to start such psychotherapy during this study
  11. Current use of any other form of treatment for depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01468610

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Canada, British Columbia
University of British Columbia, Department of Psychiatry
Vancouver, British Columbia, Canada, V6T 2A1
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Raymond W Lam, MD, FRCPC University of British Columbia

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of British Columbia Identifier: NCT01468610     History of Changes
Other Study ID Numbers: H11-02646
WS2087153 ( Other Grant/Funding Number: Pfizer Canada Inc. )
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by University of British Columbia:
occupational functioning
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs