Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

This study is currently recruiting participants.
Verified January 2014 by University of British Columbia
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01468610
First received: November 7, 2011
Last updated: January 28, 2014
Last verified: January 2014

November 7, 2011
January 28, 2014
January 2012
June 2014   (final data collection date for primary outcome measure)
cognitive functioning as determined by neuropsychological testing [ Time Frame: change from baseline to 8 weeks ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01468610 on ClinicalTrials.gov Archive Site
work productivity as determined by rating scales [ Time Frame: change from baseline to 8 weeks ] [ Designated as safety issue: No ]
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)
Same as current
Not Provided
Not Provided
 
Neurocognition and Work Productivity in Major Depressive Disorder (MDD)
Neurocognition and Work Productivity in Major Depressive Disorder

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: desvenlafaxine
50-100 mg daily for 8 weeks
Other Name: Pristiq
Active Comparator: Workers with MDD
Intervention: Drug: desvenlafaxine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
19 Years to 55 Years
No
Contact: Cindy Woo 604-822-7627 cinw@interchange.ubc.ca
Canada
 
NCT01468610
H11-02646, WS2087153
No
University of British Columbia
University of British Columbia
Pfizer
Principal Investigator: Raymond W Lam, MD, FRCPC University of British Columbia
University of British Columbia
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP