Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT01468610

Collaborator

Pfizer (Industry)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: desvenlafaxine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neurocognition and Work Productivity in Major Depressive Disorder

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Workers with MDD

Drug: desvenlafaxine

50-100 mg daily for 8 weeks

Other Names:

Pristiq

Outcome Measures

Primary Outcome Measures

cognitive functioning as determined by neuropsychological testing [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 Outcome Measures

work productivity as determined by rating scales [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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