Back to resultsNeurocognition and Work Productivity in Major Depressive Disorder (MDD)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
desvenlafaxine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, cognition, occupational functioning, productivity, neuropsychology, desvenlafaxine, antidepressants
Eligibility Criteria
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
Sites / Locations
- University of British Columbia, Department of Psychiatry
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Workers with MDD
Arm Description
Outcomes
Primary Outcome Measures
cognitive functioning as determined by neuropsychological testing
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
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)
Full Information
NCT ID
NCT01468610
First Posted
November 7, 2011
Last Updated
April 8, 2015
Sponsor
University of British Columbia
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01468610
Brief Title
Neurocognition and Work Productivity in Major Depressive Disorder (MDD)
Official Title
Neurocognition and Work Productivity in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, cognition, occupational functioning, productivity, neuropsychology, desvenlafaxine, antidepressants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Workers with MDD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine
Other Intervention Name(s)
Pristiq
Intervention Description
50-100 mg daily for 8 weeks
Primary Outcome Measure Information:
Title
cognitive functioning as determined by neuropsychological testing
Description
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)
Time Frame
change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
work productivity as determined by rating scales
Description
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)
Time Frame
change from baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond W Lam, MD, FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia, Department of Psychiatry
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30583256
Citation
Alonso-Prieto E, Rubino C, Lucey M, Evans VC, Tam EM, Woo C, Iverson GL, Chakrabarty T, Yatham LN, Lam RW. Relationship between work functioning and self-reported cognitive complaints in patients with major depressive disorder treated with desvenlafaxine. Psychiatry Res. 2019 Feb;272:144-148. doi: 10.1016/j.psychres.2018.12.062. Epub 2018 Dec 10.
Results Reference
derived
PubMed Identifier
28763344
Citation
Sarfati D, Evans VC, Tam EM, Woo C, Iverson GL, Yatham LN, Lam RW. The impact of fatigue and energy on work functioning and impairment in patients with major depressive disorder treated with desvenlafaxine. Int Clin Psychopharmacol. 2017 Nov;32(6):343-349. doi: 10.1097/YIC.0000000000000192.
Results Reference
derived
PubMed Identifier
27280963
Citation
Lam RW, Iverson GL, Evans VC, Yatham LN, Stewart K, Tam EM, Axler A, Woo C. The effects of desvenlafaxine on neurocognitive and work functioning in employed outpatients with major depressive disorder. J Affect Disord. 2016 Oct;203:55-61. doi: 10.1016/j.jad.2016.05.074. Epub 2016 May 31.
Results Reference
derived
Links:
URL
http://www.ubc.ca
Description
University of British Columbia
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Neurocognition and Work Productivity in Major Depressive Disorder (MDD)
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