Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 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: June 5, 2014
Last verified: June 2014
  Purpose

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 Intervention
Major Depressive Disorder
Drug: desvenlafaxine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurocognition and Work Productivity in Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Workers with MDD Drug: desvenlafaxine
50-100 mg daily for 8 weeks
Other Name: Pristiq

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468610

Contacts
Contact: Cindy Woo 604-822-7627 cinw@interchange.ubc.ca

Locations
Canada, British Columbia
University of British Columbia, Department of Psychiatry Recruiting
Vancouver, British Columbia, Canada, V6T 2A1
Sub-Investigator: Grant L Iverson, PhD, RPsych         
Sub-Investigator: David J Bond, MD, FRCPC         
Sub-Investigator: Lakshmi N Yatham, MBBS, FRCPC         
Sponsors and Collaborators
University of British Columbia
Pfizer
Investigators
Principal Investigator: Raymond W Lam, MD, FRCPC University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01468610     History of Changes
Other Study ID Numbers: H11-02646, WS2087153
Study First Received: November 7, 2011
Last Updated: June 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
depression
cognition
occupational functioning
productivity
neuropsychology
desvenlafaxine
antidepressants

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
O-desmethylvenlafaxine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014