Clinical trial NCT01468610: Neurocognition and Work Productivity in Major Depressive Disorder (MDD)
Official title: Neurocognition and Work Productivity in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
cognition
occupational functioning
productivity
neuropsychology
desvenlafaxine
antidepressants
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-11-09
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: cognitive functioning as determined by neuropsychological testing
timeFrame: change from baseline to 8 weeks
Secondary outcomes:
measure: work productivity as determined by rating scales
timeFrame: change from baseline to 8 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia, Department of Psychiatry
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Raymond W Lam, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.