Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

NCT01468610

Last updated date
Study Location
University of British Columbia, Department of Psychiatry
Vancouver, British Columbia, V6T 2A1, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
Descriptive Information
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 *

*   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
 (submitted: April 8, 2015)
47
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2011)
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:

  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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Raymond W Lam, MD, FRCPCUniversity of British Columbia
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