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This study aims to investigate reward learning across the mood disorder spectrum and to investigate the predictive validity of reward learning for subsequent symptom severity.
The study involves five sessions. In the first session, participants will play a computer task. In the second session, participants will go through a clinical interview and will have an EEG recording while playing another computer task. In the third session, participants will undergo an fMRI scan while playing another computer task. All tasks assess reward learning. At three and six months after the final session, participants will come back for a follow-up interview session during which a clinician will assess symptom severity. There will be no intervention in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mood disorder patients | Patients with depressive and/or manic or hypomanic symptoms | ||
| Healthy controls | Participants with no lifetime history of psychiatric illness |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Response Bias | The Probabilistic Reward Task (PRT) is a behavioral task that measures an individual's ability to learn to choose a more rewarding outcome versus a less rewarding one (Response Bias). The response bias score is a ratio of the number of times a participant correctly chooses the high reward stimulus (the "rich" stimulus) versus the low reward stimulus (the "lean" stimulus). Response bias scores range between -1 and +1. A higher Response Bias score indicates a stronger bias toward the rich stimulus, and a negative Response Bias indicates a stronger bias toward the lean stimulus. The Change-in-Response-Bias is calculated by subtracting Response Bias in block 1 (trials 0-100) of the task from Response Bias in block 3 (trials 201-300) of the task. This metric represents the degree to which an individual is able to update behavior as a function of the asymmetrical reinforcement schedule. | Administered during the first session. |
| Mean Accuracy on Gain Trials During an Instrumental Learning Task | The instrumental learning task requires participants to choose between two abstract symbols. Each symbol in the pair is associated with an 80% or 20% probability of a given outcome (gain: win $1 or $0; loss: lose $1 or $0; neutral: view a gray square or see the word 'nothing'). The task consists of three blocks. Behavioral performance focuses on the number of times the participant chose the symbol that was associated more frequently associated with the more desirable outcome. A participant scores 1 if they choose correctly, and 0 if they choose in correctly, and correct choices across all three blocks are added and converted to a percentage relative to the total number of trials in that condition (i.e., gain, loss, or neutral). This study focused on percent of accuracy responses in the gain condition. | Administered in session 3 during 1.5 hour MR scan |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Severity at 6 Month Follow-up |
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Inclusion Criteria:
Written informed consent
Right-handed
(For mood disorder group only) Stable medication over the past 8 weeks OR absence of any psychotropic medications for at least 2 weeks (for follow-up analyses testing effects in medication-free patients):
Exclusion Criteria:
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We are studying a population with depressive and/or manic or hypomanic symptoms, as well as healthy controls.
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| Name | Affiliation | Role |
|---|---|---|
| Diego A Pizzagalli, Ph.D. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37841877 | Derived | Pizzagalli D, Whitton A, Treadway M, Rutherford A, Kumar P, Ironside M, Kaiser R, Ren B, Dan R. Brain-based graph-theoretical predictive modeling to map the trajectory of transdiagnostic symptoms of anhedonia, impulsivity, and hypomania from the human functional connectome. Res Sq [Preprint]. 2023 Sep 28:rs.3.rs-3168186. doi: 10.21203/rs.3.rs-3168186/v1. | |
| 37402852 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mood Disorder Patients | Patients with depressive and/or manic or hypomanic symptoms |
| FG001 | Healthy Controls | Participants with no lifetime history of psychiatric illness |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mood Disorder Patients | Patients with depressive and/or manic or hypomanic symptoms |
| BG001 | Healthy Controls | Participants with no lifetime history of psychiatric illness |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Response Bias | The Probabilistic Reward Task (PRT) is a behavioral task that measures an individual's ability to learn to choose a more rewarding outcome versus a less rewarding one (Response Bias). The response bias score is a ratio of the number of times a participant correctly chooses the high reward stimulus (the "rich" stimulus) versus the low reward stimulus (the "lean" stimulus). Response bias scores range between -1 and +1. A higher Response Bias score indicates a stronger bias toward the rich stimulus, and a negative Response Bias indicates a stronger bias toward the lean stimulus. The Change-in-Response-Bias is calculated by subtracting Response Bias in block 1 (trials 0-100) of the task from Response Bias in block 3 (trials 201-300) of the task. This metric represents the degree to which an individual is able to update behavior as a function of the asymmetrical reinforcement schedule. | Population includes patients and healthy controls who completed the PRT during the first session. | Posted | Mean | Full Range | log-transformed ratio of scores | Administered during the first session. |
|
Adverse event data was collected from the date of subject consent until the conclusion of the 6-month follow-up interview (or until the subject was lost to contact).
Definitions do not differ from the clinicaltrials.gov definition of adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mood Disorder Patients | Patients with depressive and/or manic or hypomanic symptoms |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Crowley | McLean Hospital | 6178554432 | djcrowley@mclean.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2017 | Jun 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| 6 months |
| Whitton AE, Kumar P, Treadway MT, Rutherford AV, Ironside ML, Foti D, Fitzmaurice G, Du F, Pizzagalli DA. Distinct profiles of anhedonia and reward processing and their prospective associations with quality of life among individuals with mood disorders. Mol Psychiatry. 2023 Dec;28(12):5272-5281. doi: 10.1038/s41380-023-02165-1. Epub 2023 Jul 4. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Beck Depression Inventory-II | Beck Depression Inventory-II (BDI-II). Measures the presence and severity of 21 depressive symptoms during the past two weeks, on a scale from 0 (none, or no change) to 3 (persistent, or worsening). Range: 0 to 63. Higher scores indicate greater symptom severity. Clinical categories for total score: 0-14: absent; 14-19: mild; 20-28: moderate; 29-63: severe. | Mean | Full Range | units on a scale |
|
| Young Mania Rating Scale | The YMRS is an 11-item scale that assesses manic symptoms based on the participant's report of his or her condition over the previous 48 hours, as well as the assessor's observations. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate/amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). | The YMRS was not administered to subjects in the Healthy Control arm. | Mean | Full Range | units on a scale |
|
| OG000 | Mood Disorder Patients | Patients with depressive and/or manic or hypomanic symptoms |
| OG001 | Healthy Controls | Participants with no lifetime history of psychiatric illness |
|
|
| Primary | Mean Accuracy on Gain Trials During an Instrumental Learning Task | The instrumental learning task requires participants to choose between two abstract symbols. Each symbol in the pair is associated with an 80% or 20% probability of a given outcome (gain: win $1 or $0; loss: lose $1 or $0; neutral: view a gray square or see the word 'nothing'). The task consists of three blocks. Behavioral performance focuses on the number of times the participant chose the symbol that was associated more frequently associated with the more desirable outcome. A participant scores 1 if they choose correctly, and 0 if they choose in correctly, and correct choices across all three blocks are added and converted to a percentage relative to the total number of trials in that condition (i.e., gain, loss, or neutral). This study focused on percent of accuracy responses in the gain condition. | All participants who had readable Pessiglione task data | Posted | Mean | Full Range | Percent of accurate responses | Administered in session 3 during 1.5 hour MR scan |
|
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| Secondary | Symptom Severity at 6 Month Follow-up |
| Population includes patients and controls who completed the 6-month follow up session | Posted | Mean | Full Range | units on a scale | 6 months |
|
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|
| 0 |
| 226 |
| 0 |
| 226 |
| 0 |
| 226 |
| EG001 | Healthy Controls | Participants with no lifetime history of psychiatric illness | 0 | 44 | 0 | 44 | 0 | 44 |
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| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| TEPS Anticipatory Pleasure Scale |
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| TEPS Consummatory Pleasure Scale |
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| MASQ-AD; Anhedonic Depression severity |
|
| BIS Impulsiveness |
|