Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title:

Neurocognition and Work Productivity in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468610
• Other study ID #: H11-02646
• Secondary ID: WS2087153
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: April 8, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• desvenlafaxine
50-100 mg daily for 8 weeks

Locations

Country	Name	City	State
Canada	University of British Columbia, Department of Psychiatry	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	change from baseline to 8 weeks	No

External Links

•   University of British Columbia