Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

NCT ID: NCT01468610

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Workers with MDD

Group Type ACTIVE_COMPARATOR

desvenlafaxine

Intervention Type DRUG

50-100 mg daily for 8 weeks

Interventions

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desvenlafaxine

50-100 mg daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Pristiq

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond W Lam, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia, Department of Psychiatry

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 30583256 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28763344 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27280963 (View on PubMed)

Related Links

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http://www.ubc.ca

University of British Columbia

Other Identifiers

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WS2087153

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H11-02646

Identifier Type: -

Identifier Source: org_study_id

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