Neurocognition and Work Productivity in Major Depressive Disorder (MDD)
NCT01468610
ABOUT THIS STUDY
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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
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
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Descriptive Information | ||||
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Brief Title ICMJE | Neurocognition and Work Productivity in Major Depressive Disorder (MDD) | |||
Official Title ICMJE | Neurocognition and Work Productivity in Major Depressive Disorder | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Major Depressive Disorder | |||
Intervention ICMJE | Drug: desvenlafaxine
50-100 mg daily for 8 weeks Other Name: Pristiq | |||
Study Arms ICMJE | Active Comparator: Workers with MDD
Intervention: Drug: desvenlafaxine | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 47 | |||
Original Estimated Enrollment ICMJE | 50 | |||
Actual Study Completion Date ICMJE | December 2014 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 19 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01468610 | |||
Other Study ID Numbers ICMJE | H11-02646 WS2087153 ( Other Grant/Funding Number: Pfizer Canada Inc. ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of British Columbia | |||
Study Sponsor ICMJE | University of British Columbia | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | University of British Columbia | |||
Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |