Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

NCT01468610 | Completed

• 2 other identifiers: H11-02646WS2087153
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

depression; cognition; occupational functioning; productivity; neuropsychology; desvenlafaxine; antidepressants

Outcome Measures

Primary Outcomes (1)

• 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)

  change from baseline to 8 weeks

Secondary Outcomes (1)

• work productivity as determined by rating scales

  change from baseline to 8 weeks

Study Arms (1)

Workers with MDD

ACTIVE COMPARATOR

Drug: desvenlafaxine

Interventions

desvenlafaxine DRUG

50-100 mg daily for 8 weeks

Also known as: Pristiq

Workers with MDD

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Pfizer: collaborator

Study Sites (1)

University of British Columbia, Department of Psychiatry

Vancouver, British Columbia, V6T 2A1, Canada

Location

Related Publications (3)

• 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.

  PMID: 30583256 DERIVED

• 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.

  PMID: 28763344 DERIVED

• 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.

  PMID: 27280963 DERIVED

Related Links

• University of British Columbia

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Study Officials

• Raymond W Lam, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

CA (1)