DepressionPhase 4NCT02859103
Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Pre- and Post-Desvenlafaxine Treatment
A Phase 4 study testing Desvenlafaxine in people with Depression and Anhedonia, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Anhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major depressive disorder (MDD), and it may impact how patients with depression experience reward. Understanding how anhedonia is related to the experience of reward may help improve how depression is treated. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anhedonia
- What is being tested?
- Desvenlafaxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 4 Nov 2019
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DSM-5 criteria for Major Depressive Episode (MDE) within a MDD, confirmed through MINI diagnosis
- Age between 18 and 60 years
- Hamilton Depression Rating Scale - 17 item (HRSD-17)58 > 17 (moderate to severe symptoms)
- Free of psychotropic medications for at least 5 half-lives before baseline visit
- Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)
- Age between 18 and 60 years
- Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)
Who cannot join
- Pregnancy/lactation
- Medical condition requiring immediate investigation or treatment
- Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
- Lifetime history of psychosis, other Axis I comorbidities are allowable
- Significant Axis II diagnosis
- Previous intolerance or failure to respond to an adequate trial of desvenlafaxine
Show all 12Show fewer
- Failure of > 2 antidepressant treatments of adequate dose and duration for current MDE
- Inclusion/exclusion criteria for Healthy Controls (n=20) are as follows:
- Pregnancy/lactation
- Medical condition requiring immediate investigation or treatment
- Lifetime history of any psychiatric disorder
- Lifetime history of receiving an antidepressant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Before and After Treatment With Desvenlafaxine
Anhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major depressive disorder (MDD), and it may impact how patients with depression experience reward. Understanding how anhedonia is related to the experience of reward may help improve how depression is treated. Computer tasks can be used to measure how reward is experienced, and these measures might be able to predict things like who is likely to become depressed, or who will respond to antidepressant medication. Studying the relationship between anhedonia and reward in patients with depression might also tell us something about how to improve diagnosis and treatment of other psychiatric disorders.This is an open label controlled treatment study lasting 8 weeks. The brain scans will be used to find changes in brain areas that may be related to how people perform on the tasks. The investigators goal is to use this information to help us find a reliable predictor that can be used to guide MDD treatment.
- Conditions
- Depression, Anhedonia
- Being tested
- Desvenlafaxine
- Medical subject headings
- Depression, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesvenlafaxineDrug
Also called Pristiq
Patients will be provided 50mg dose of desvenlafaxine for 1 week titrated up to 100mg dose of desvenlafaxine for 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Patients in this arm will receive treatment with desvenlafaxine for 8 weeks. Receives: Drug: Desvenlafaxine |
| Healthy Control | No intervention | Patients in this arm are healthy controls and will not receive any medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Reward association and valuation using the Reward Association Task
Based on signal detection theory, it evaluates response bias as a function of prior reward and permits an objective assessment of disorder-related sensitivity to reward. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Measured: Change from Baseline at 8 Weeks
Measuring Expectation using a prediction error task, to measure learning and choosing, during functional Magnetic Resonance Imaging (fMRI)
This distinction was included in the design in order to dissociate potentially different neural circuits subserving learning reward associations and using them to guide behavior. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Measured: Change from Baseline at 8 Weeks
Anticipation of reward using the monetary incentive delay during fMRI
This task was designed to disentangle anticipatory vs. consummatory phases of reward processing. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Measured: Change from Baseline at 8 Weeks
Motivation/effort using the Cued-Reinforcement Reaction Time Task and the EEfRT task.
The Cued-Reinforcement Reaction Time Task (CRRT) provides an evaluation of reward-based reaction time speed as an index of incentive motivation.The EEfRT task allows analysis of the predictive value of reward probability and magnitude on effort-based decision making. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Measured: Change from Baseline at 8 Weeks
Pleasure/Liking using the monetary incentive delay task in an fMRI
This task was designed to disentangle anticipatory vs. consummatory phases of reward processing. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Measured: Change from Baseline at 8 Weeks
Feedback integration using the Probabilistic Reversal Learning task during fMRI
participants are presented with a choice of two stimuli. Based on their first choice, the selected stimulus will be rewarded with a high probability, while the other will be rewarded with a low probability.To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Measured: Change from Baseline at 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start1 Jun 2017
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sakina Rizvi, Unity Health Toronto
- Investigators
- Sakina Rizvi, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859103
- Sponsor's protocol ID
- DVS-01
- Status last verified
- Oct 2020
- First submitted
- 15 Jul 2016
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Before and After Treatment With Desvenlafaxine
- ClinicalTrials.gov ID
- NCT02859103
- Acronym / sponsor ID
- DVS-01
- Conditions
- Depression, Anhedonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 8 Aug 2016 (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.
Anhedonia (the lack of pleasure in normally pleasurable things) is a common symptom of major depressive disorder (MDD), and it may impact how patients with depression experience reward. Understanding how anhedonia is related to the experience of reward may help improve how depression is treated. Computer tasks can be used to measure how reward is experienced, and these measures might be able to predict things like who is likely to become depressed, or who will respond to antidepressant medication. Studying the relationship between anhedonia and reward in patients with depression might also tell us something about how to improve diagnosis and treatment of other psychiatric disorders.This is an open label controlled treatment study lasting 8 weeks. The brain scans will be used to find changes in brain areas that may be related to how people perform on the tasks. The investigators goal is to use this information to help us find a reliable predictor that can be used to guide MDD treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: DesvenlafaxinePatients in this arm will receive treatment with desvenlafaxine for 8 weeks. |
| Healthy Control | No intervention | –Patients in this arm are healthy controls and will not receive any medication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- DSM-5 criteria for Major Depressive Episode (MDE) within a MDD, confirmed through MINI diagnosis
- Age between 18 and 60 years
- Hamilton Depression Rating Scale - 17 item (HRSD-17)58 > 17 (moderate to severe symptoms)
- Free of psychotropic medications for at least 5 half-lives before baseline visit
- Ability to undergo MRI scanning (absence of metal, pacemakers, etc.)
Key exclusion criteria (12 listed)
- Pregnancy/lactation
- Medical condition requiring immediate investigation or treatment
- Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine, or nicotine)
- Lifetime history of psychosis, other Axis I comorbidities are allowable
- Significant Axis II diagnosis
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: PristiqPatients will be provided 50mg dose of desvenlafaxine for 1 week titrated up to 100mg dose of desvenlafaxine for 7 weeks. | Drug | Treatment |
Primary outcome
Measuring Reward association and valuation using the Reward Association Task
Time frame: Change from Baseline at 8 Weeks
Based on signal detection theory, it evaluates response bias as a function of prior reward and permits an objective assessment of disorder-related sensitivity to reward. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Measuring Expectation using a prediction error task, to measure learning and choosing, during functional Magnetic Resonance Imaging (fMRI)
Time frame: Change from Baseline at 8 Weeks
This distinction was included in the design in order to dissociate potentially different neural circuits subserving learning reward associations and using them to guide behavior. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Anticipation of reward using the monetary incentive delay during fMRI
Time frame: Change from Baseline at 8 Weeks
This task was designed to disentangle anticipatory vs. consummatory phases of reward processing. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Motivation/effort using the Cued-Reinforcement Reaction Time Task and the EEfRT task.
Time frame: Change from Baseline at 8 Weeks
The Cued-Reinforcement Reaction Time Task (CRRT) provides an evaluation of reward-based reaction time speed as an index of incentive motivation.The EEfRT task allows analysis of the predictive value of reward probability and magnitude on effort-based decision making. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Pleasure/Liking using the monetary incentive delay task in an fMRI
Time frame: Change from Baseline at 8 Weeks
This task was designed to disentangle anticipatory vs. consummatory phases of reward processing. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways. To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
Feedback integration using the Probabilistic Reversal Learning task during fMRI
Time frame: Change from Baseline at 8 Weeks
participants are presented with a choice of two stimuli. Based on their first choice, the selected stimulus will be rewarded with a high probability, while the other will be rewarded with a low probability.To evaluate the how the 6 facets of reward are related to each other in unmedicated MDD patients in order to develop a clearer understanding of reward pathways
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 2 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Sakina Rizvi, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desvenlafaxine in people with Depression and Anhedonia, run by Unity Health Toronto 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 7 inclusion and 12 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 2 Nov 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Measuring Reward association and valuation using the Reward Association Task (time frame: Change from Baseline at 8 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2020; AzTrials last refreshed its copy on 30 Oct 2026.