Major Depressive DisorderNCT01468610
Neurocognition and Work Productivity in Major Depressive Disorder (MDD)
A study testing desvenlafaxine in people with Major Depressive Disorder, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- desvenlafaxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- (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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Department of Psychiatry
Vancouver, British Columbia, V6T 2A1
About this study
Official title: Neurocognition and Work Productivity in Major Depressive Disorder
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.
- Conditions
- Major Depressive Disorder
- Being tested
- desvenlafaxine
- Keywords
- depression, cognition, occupational functioning, productivity, neuropsychology, desvenlafaxine, antidepressants
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desvenlafaxineDrug
Also called Pristiq
50-100 mg daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Workers with MDD | Active comparator | Not described Receives: Drug: desvenlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: change from baseline to 8 weeks
Secondary outcomes (1)
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)
Measured: change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Raymond W Lam, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468610
- Sponsor's protocol ID
- H11-02646
- Other IDs
- WS2087153
- Status last verified
- Apr 2015
- First submitted
- 7 Nov 2011
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30583256Sarfati 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.
PubMed 28763344Lam 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.
PubMed 27280963
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognition and Work Productivity in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01468610
- Acronym / sponsor ID
- H11-02646
- Conditions
- Major Depressive Disorder
- Keywords
- depression, cognition, occupational functioning, productivity, neuropsychology, desvenlafaxine, antidepressants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Workers with MDD | Active comparator | Drug: desvenlafaxine |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desvenlafaxineAlso: Pristiq50-100 mg daily for 8 weeks | Drug | Workers with MDD |
Primary outcome
cognitive functioning as determined by neuropsychological testing
Time frame: 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)
1 secondary outcome
work productivity as determined by rating scales
Time frame: change from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
- Derived from this study: PubMed 30583256Alonso-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.
- Derived from this study: PubMed 28763344Sarfati 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.
- Derived from this study: PubMed 27280963Lam 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.
- University of British ColumbiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond W Lam, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing desvenlafaxine in people with Major Depressive Disorder, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive functioning as determined by neuropsychological testing (time frame: change from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01468610, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.