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.
Condition or disease |
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Anhedonia Obesity |
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 Type : | Observational |
Estimated Enrollment : | 20 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | Evaluating Motivation and Reward Mechanisms and Brain Substrates in Adults With Obesity: Further Evidence That Obesity Affects Physical and Mental Health |
Actual Study Start Date : | October 30, 2019 |
Estimated Primary Completion Date : | August 1, 2020 |
Estimated Study Completion Date : | September 1, 2020 |
Group/Cohort |
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Major Depressive Disorder or Bipolar Disorder
All eligible participants will be included in this single study arm.
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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:
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.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
All subjects will be consented prior to initiating the study; >45 BMI; suicidality as determined by clinical discretion
Contact: Hartej Gill, BSc | 416-430-9619 | hartej.gill@mail.utoronto.ca | |
Contact: Nelson Rodrigues, MSc | 416-430-9619 | nelson.rodrigues@crtce.com |
Canada, Ontario | |
Canadian Rapid Treatment Centre of Excellence | Recruiting |
Mississauga, Ontario, Canada, L5C 4E7 | |
Contact: Hartej Gill, BSc 416-430-9619 hartej.gill@mail.utoronto.ca |
Tracking Information | |||||||||
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First Submitted Date | April 25, 2019 | ||||||||
First Posted Date | May 7, 2019 | ||||||||
Last Update Posted Date | December 24, 2019 | ||||||||
Actual Study Start Date | October 30, 2019 | ||||||||
Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
MRI/DTI [ Time Frame: 1 day ] 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:
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Evaluating Motivation and Reward Mechanisms and Brain Substrates in Adults With Obesity | ||||||||
Official Title | Evaluating Motivation and Reward Mechanisms and Brain Substrates in Adults With Obesity: Further Evidence That Obesity Affects Physical and Mental Health | ||||||||
Brief 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. 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. |
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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). |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Other Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Probability Sample | ||||||||
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). | ||||||||
Condition |
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Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Major Depressive Disorder or Bipolar Disorder
All eligible participants will be included in this single study arm.
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
20 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | September 1, 2020 | ||||||||
Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
All subjects will be consented prior to initiating the study; >45 BMI; suicidality as determined by clinical discretion |
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Canada | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03939676 | ||||||||
Other Study ID Numbers | Pro00032575 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Dr. Roger S. McIntyre, Brain and Cognition Discovery Foundation | ||||||||
Study Sponsor | Brain and Cognition Discovery Foundation | ||||||||
Collaborators | Not Provided | ||||||||
Investigators | Not Provided | ||||||||
PRS Account | Brain and Cognition Discovery Foundation | ||||||||
Verification Date | December 2019 |