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Completed

NCT Number: NCT01468610

Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Department of Psychiatry

Vancouver, British Columbia, V6T 2A1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Current receipt of short-term or long-term disability benefits from employer
  • Serious suicidal risks as judged by the investigators
  • Other DSM-IV-TR diagnoses:
  • organic mental disorders
  • active substance abuse/dependence, including alcohol
  • schizophrenia, paranoid or delusional disorders, or other psychotic disorders
  • (as primary diagnosis:) panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder
  • bipolar disorder
  • bulimia nervosa or anorexia nervosa
  • Serious illness that is not stabilized, including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease
  • Regular/current use of other psychotropic drugs and/or herbaceuticals
  • 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)
  • Previous treatment with desvenlafaxine
  • 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
  • Any history of treatment with electroconvulsive therapy
  • 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
  • Current use of any other form of treatment for depression

Treatment and study plan

Desvenlafaxine

Drug

50-100 mg daily for 8 weeks

Other names: Pristiq

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Pfizer

Registry information

Official study title

Neurocognition and Work Productivity in Major Depressive Disorder

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 9, 2011
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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