AnhedoniaNCT03939676
Evaluating Motivation and Reward Mechanisms and Brain Substrates in Adults With Obesity
An observational study of Anhedonia and Obesity, run by Brain and Cognition Discovery Foundation at 1 site in Canada.
Trial summary
Anhedonia and abnormalities in reward behavior are core features of overweight/obesity (OW), a highly prevalent condition within MDD populations, and is independently associated with reward disturbances. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2019to 15 Dec 2020
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be identified at the Brain and Cognition Discovery Foundation (BCDF). Twenty subjects between the ages of 18-65 years with obesity, will be enrolled. All patients will be assessed for concurrent psychiatric disorders (e.g. mood disorders) and will meet DSM-V criteria for either: major depressive disorder (symptomatic or asymptomatic in any phase of the illness) or bipolar disorder I/II (symptomatic or asymptomatic in any phase of the illness).
Who may be able to join
- 18-65 years of age
- Meeting DSM-V criteria for: (i) Major depressive disorder (symptomatic or asymptomatic in any phase of the illness) or (ii) bipolar disorder I/II (symptomatic or asymptomatic in any phase of the illness)
- Ability to provide written and informed consent
- Obesity 30 kg/m2
- Weight under 440lbs
- Shoulder-to-shoulder width under 60 cm
Who cannot join
- Age below 18 or above 65
- Use of benzodiazepines or consumption of alcohol within 12 hours of assessments
- Abuse of marijuana
- Physical, cognitive, or language impairments sufficient to adversely affect data derived from assessments
- Diagnosed reading disability or dyslexia
- Clinically significant learning disorder by history
Show all 13Show fewer
- History of moderate or severe traumatic brain injury
- Other neurological disorders, or unstable systemic medical diseases
- Pregnancy and post-partum period
- Presence of any contra-indications for MRI
- Weight above 440lbs
- Shoulder-to-shoulder width greater than 60 cm.
- All subjects will be consented prior to initiating the study; >45 BMI; suicidality as determined by clinical discretion
Trial locations and contacts
1 site in 1 country.
Canada1 site
Canadian Rapid Treatment Centre of Excellence
Mississauga, Ontario, L5C 4E7
About this study
Official title: Evaluating Motivation and Reward Mechanisms and Brain Substrates in Adults With Obesity: Further Evidence That Obesity Affects Physical and Mental Health
Anhedonia and abnormalities in reward behavior are core features of overweight/obesity (OW), a highly prevalent condition within MDD populations, and is independently associated with reward disturbances. The investigators therefore aim to investigate the brain substrates subserving reward and motivation in adults with overweight/obesity.
The primary aim of this pilot study is to determine whether associations exist between obesity and decreased performance on the respective motivation/reward paradigms.
Read the detailed description
Herein, the investigators are primarily interested in three overlapping, yet distinct aspects, of anhedonia. The investigators are primarily interested in motivation, reward valuation, and reward learning towards addressing the measurement of each of these respective subdomains, eligible participants will complete validated gold standard measures (i.e. the Effort Expenditure for Rewards Task (EEfRT) (reward valuation), Probabilistic Reward Task (PRT) (reward learning), and the Monetary Incentive Delay (MID) task (reward anticipation)).
Twenty adults with overweight/obesity will complete all tasks at a single visit with two of the tasks being completed prior to MRI and one of the tasks (i.e. EEfRT) will be completed during MRI acquisition.
The primary aim of this pilot study is to determine whether associations exist between obesity and decreased performance on the respective motivation/reward paradigms. In addition, associations between performance on reward tasks and functional connectivity, as measured by MRI and DTI, a secondary objective is to ascertain whether associations exist between performance on the motivation reward tasks and gold standard measures of food intake (i.e. food diary) and energy expenditure (i.e. calorimetry).
- Medical subject headings
- Anhedonia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder or Bipolar Disorder | All eligible participants will be included in this single study arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effort Expenditure for Rewards Task (EEfRT)
The EEfRT task is a behavioural paradigm that is used to investigate the subject's effort-based decision-making. Subjects are presented with a series of repeated trials wherein they must choose between performing a hard task or an easy task in order to receive monetary compensation (subject's will receive greater compensation for completing the hard task and less compensation for completing the easy task). By presenting the subject with different probability levels for reward receipt, the objective is to examine the extent to which the relationship between motivation (i.e., anhedonia) and effort-based decision-making is modulated by perceived reward magnitude.
Measured: 1 day
Monetary Incentive Delay (MID) Task
The MID is a behavioural paradigm that assesses the basis of anticipation and consumption of reward and punishment. Each run of the MID task consists of approximately 72 trials. The types of cues presented include: circles (indicating the potential to win money i.e., gain cue), squares (indicating the potential to lose money i.e., loss cue), and a triangle (indicating no money will be won or lost i.e., neutral cue). A cue is presented for 500 ms, followed by a fixation cross (2,000 to 2,500 ms) and then the target square (160 to 260 ms), during which the participant is instructed to press a button as quickly as possible to win or avoid losing money. A feedback screen (1,650 ms), in which the top number indicates the amount of money won or lost during that trial, and the bottom number indicates the participant's total amount, is presented at the end of each trial.
Measured: 1 day
Probablistic Reward Task (PRT)
The PRT is a behavioural paradigm that measures response bias and sensitivity to reward under variable conditions. In this task, a signal detection approach is used, whereby subjects must discriminate between two non-ambiguous stimuli displayed rapidly on a computer screen in order to receive a monetary reward. Unbeknownst to the subjects, correct identification of one stimulus is reinforced three times more frequently than the other stimulus. Under these experimental circumstances, healthy subjects reliably develop a response bias for the stimulus that is reinforced more frequently, regardless of which stimulus was actually presented. Thus, reward responsiveness assessed in this task reflects the rapid shaping of future behavioral choices based on prior reinforcement experiences.
Measured: 1 day
Secondary outcomes (1)
MRI/DTI
The secondary outcome will be the association between the EEfRT and function reciprocity of the reward circuit/cognitive control network as measured by MRI/DTI.
Subjects will be scanned using a 3.0-Tesla Signa HDx scanner with an 8-channel phased-array receiver coil consisting of a structural and functional neuroimaging, comprising:
- Whole-brain 3-D T1-weighted Inversion-Recovery prepared Fast Spoiled Gradient-Echo anatomical scan
- Whole-brain, T2*-weighted BOLD echo planar imaging during awake resting state
- Three runs of whole-brain, T2*-weighted BOLD EPI series during task-based reward paradigm.
Graph theoretical analysis will be used to assess functional connectivity of the default mode network, cognitive control network, affect network and reward network.
Associations between obesity and alterations in functional connectivity will be the outcome of interest.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start30 Oct 2019
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnhedoniaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain and Cognition Discovery Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger McIntyre, Brain and Cognition Discovery Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939676
- Sponsor's protocol ID
- Pro00032575
- Status last verified
- Jul 2021
- First submitted
- 25 Apr 2019
- Last updated
- 29 Jul 2021
- 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 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Motivation and Reward Mechanisms and Brain Substrates in Adults With Obesity: Further Evidence That Obesity Affects Physical and Mental Health
- ClinicalTrials.gov ID
- NCT03939676
- Acronym / sponsor ID
- Pro00032575
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Brain and Cognition Discovery FoundationUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 7 May 2019 (actual)
- 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 and abnormalities in reward behavior are core features of overweight/obesity (OW), a highly prevalent condition within MDD populations, and is independently associated with reward disturbances. The investigators therefore aim to investigate the brain substrates subserving reward and motivation in adults with overweight/obesity.
The primary aim of this pilot study is to determine whether associations exist between obesity and decreased performance on the respective motivation/reward paradigms.
Detailed description
Herein, the investigators are primarily interested in three overlapping, yet distinct aspects, of anhedonia. The investigators are primarily interested in motivation, reward valuation, and reward learning towards addressing the measurement of each of these respective subdomains, eligible participants will complete validated gold standard measures (i.e. the Effort Expenditure for Rewards Task (EEfRT) (reward valuation), Probabilistic Reward Task (PRT) (reward learning), and the Monetary Incentive Delay (MID) task (reward anticipation)).
Twenty adults with overweight/obesity will complete all tasks at a single visit with two of the tasks being completed prior to MRI and one of the tasks (i.e. EEfRT) will be completed during MRI acquisition.
The primary aim of this pilot study is to determine whether associations exist between obesity and decreased performance on the respective motivation/reward paradigms. In addition, associations between performance on reward tasks and functional connectivity, as measured by MRI and DTI, a secondary objective is to ascertain whether associations exist between performance on the motivation reward tasks and gold standard measures of food intake (i.e. food diary) and energy expenditure (i.e. calorimetry).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder or Bipolar Disorder | – | –All eligible participants will be included in this single study arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified at the Brain and Cognition Discovery Foundation (BCDF). Twenty subjects between the ages of 18-65 years with obesity, will be enrolled. All patients will be assessed for concurrent psychiatric disorders (e.g. mood disorders) and will meet DSM-V criteria for either: major depressive disorder (symptomatic or asymptomatic in any phase of the illness) or bipolar disorder I/II (symptomatic or asymptomatic in any phase of the illness).
Key inclusion criteria (6 listed)
- 18-65 years of age
- Meeting DSM-V criteria for: (i) Major depressive disorder (symptomatic or asymptomatic in any phase of the illness) or (ii) bipolar disorder I/II (symptomatic or asymptomatic in any phase of the illness)
- Ability to provide written and informed consent
- Obesity 30 kg/m2
- Weight under 440lbs
Key exclusion criteria (13 listed)
- Age below 18 or above 65
- Use of benzodiazepines or consumption of alcohol within 12 hours of assessments
- Abuse of marijuana
- Physical, cognitive, or language impairments sufficient to adversely affect data derived from assessments
- Diagnosed reading disability or dyslexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effort Expenditure for Rewards Task (EEfRT)
Time frame: 1 day
The EEfRT task is a behavioural paradigm that is used to investigate the subject's effort-based decision-making. Subjects are presented with a series of repeated trials wherein they must choose between performing a hard task or an easy task in order to receive monetary compensation (subject's will receive greater compensation for completing the hard task and less compensation for completing the easy task). By presenting the subject with different probability levels for reward receipt, the objective is to examine the extent to which the relationship between motivation (i.e., anhedonia) and effort-based decision-making is modulated by perceived reward magnitude.
Monetary Incentive Delay (MID) Task
Time frame: 1 day
The MID is a behavioural paradigm that assesses the basis of anticipation and consumption of reward and punishment. Each run of the MID task consists of approximately 72 trials. The types of cues presented include: circles (indicating the potential to win money i.e., gain cue), squares (indicating the potential to lose money i.e., loss cue), and a triangle (indicating no money will be won or lost i.e., neutral cue). A cue is presented for 500 ms, followed by a fixation cross (2,000 to 2,500 ms) and then the target square (160 to 260 ms), during which the participant is instructed to press a button as quickly as possible to win or avoid losing money. A feedback screen (1,650 ms), in which the top number indicates the amount of money won or lost during that trial, and the bottom number indicates the participant's total amount, is presented at the end of each trial.
Probablistic Reward Task (PRT)
Time frame: 1 day
The PRT is a behavioural paradigm that measures response bias and sensitivity to reward under variable conditions. In this task, a signal detection approach is used, whereby subjects must discriminate between two non-ambiguous stimuli displayed rapidly on a computer screen in order to receive a monetary reward. Unbeknownst to the subjects, correct identification of one stimulus is reinforced three times more frequently than the other stimulus. Under these experimental circumstances, healthy subjects reliably develop a response bias for the stimulus that is reinforced more frequently, regardless of which stimulus was actually presented. Thus, reward responsiveness assessed in this task reflects the rapid shaping of future behavioral choices based on prior reinforcement experiences.
1 secondary outcome
MRI/DTI
Time frame: 1 day
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 29 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anhedonia and Obesity, run by Brain and Cognition Discovery Foundation 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 6 inclusion and 13 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 29 Jul 2021. 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?
Effort Expenditure for Rewards Task (EEfRT) (time frame: 1 day). The study lists 3 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 29 Jul 2021.