Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

April 8, 2015 updated by: University of British Columbia

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2A1
        • University of British Columbia, Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Workers with MDD
50-100 mg daily for 8 weeks
Other Names:
  • Pristiq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
change from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
change from baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Raymond W Lam, MD, FRCPC, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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