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| ID | Type | Description | Link |
|---|---|---|---|
| 4R37MH068376-17 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study looks at the role of the Nociceptin/Orphanin FQ receptor system in the brain of individuals with current or past major depressive disorder (MDD). It also examines how individuals with a history of depression make certain decisions and which brain regions are involved in such decisions. Information collected through MRI, PET, biospecimens (i.e., blood, saliva) and behavioral tasks will be used to predict depressive symptoms in the future.
The overarching goals of this research are to investigate: (1) the activity of the Nociceptin/Orphanin FQ receptor system among individuals with current or remitted MDD; (2) neural foundations of approach/avoidance behaviors in current or remitted MDDs; (3) stress-induced inflammation in individuals with remitted MDD; (4) neural markers that predict future disease course.
This will be achieved through an innovative method of using functional magnetic resonance imaging (fMRI) during an approach/avoidance decision-making task, in addition to a resting positron emission tomography (PET) scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDD subjects | Subjects diagnosed with Major Depression Disorder |
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| Remitted MDD subjects | Subjects with a history of major depressive disorder episode in the past |
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| Control subjects | Subjects with no history of known neurological and psychiatric illness. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aversive stimuli | Device | Electrotactile stimulation will be used as the aversive stimulus. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model DS71 has been safely implemented in studies with previously MGH-approved IRB's (Milad et al., 2013). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Interview | For assessing psychological state | Baseline |
| Behavioral Performance on the Probabilistic Reward Task (PRT) | the PRT assesses individuals' ability to learn from rewards | Baseline |
| MRI Data | For testing the neural correlates of approach-avoidance decision making behaviors | within 30 days of Screening Visit |
| Salivary Cortisol | For assessing stress level | Baseline |
| PET Data | For assessing the Nociceptin/Oprhanin FQ receptor system activity | within 30 days of Screening Visit |
| Arterial blood data | for PET modeling and assessing Nociceptin/Orphanin FQ levels in bloodstream | Baseline |
| Follow-up Clinical Interviews | To assess psychological state changes | Change from Baseline at 6 months and 12 months after the PET visit |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory-II (BDI) | self-report measure of depressive symptoms | Change from Baseline at 6 months and 12 months after the PET visit |
| Childhood Trauma Questionnaire (CTQ) | self-report measure of childhood trauma |
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Inclusion Criteria for all participants:
Inclusion Criteria for "Remitted MDD" group:
Inclusion Criteria for "Current MDD" group:
Exclusion Criteria for all participants:
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The subjects for this research will be 228 participants recruited from the community by the Center for Depression, Anxiety and Stress Research (Director: Dr. Diego Pizzagalli, Ph.D.). Demographically-matched participants will include: (1) 38 participants with current MDD; (2) 38 participants with past MDD; and (3) 38 healthy controls.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy Lam, BS | Contact | 617-855-4437 | mclrew41study@mgb.org | |
| David Crowley, ALM | Contact | 617-855-4432 | djcrowley@mclean.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Diego Pizzagalli, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Recruiting | Belmont | Massachusetts | 02478 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Saliva samples are collected seven times over the course of the MRI visit to be assayed for salivary cortisol
Blood samples are collected during the MRI visit-once before the scan and once after the scan-to processed for RNA, DNA, and serum. Processed samples will be analyzed for proinflammatory cytokines and transcription control levels.
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| PET radiotracer | Drug | A Nociceptin/Orphanin FQ ("N/OFQ") peptide tracer ([11C] NOP-1A) will be used as the PET radiotracer. Approximately 10 mCi of this tracer will be delivered intravenously as a slow bolus over 60 seconds with beginning of the PET imaging acquisition. Approximately 60 ml of blood will be drawn from an artery throughout the dynamic PET acquisition in order to measure the blood N/OFQ levels. |
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| Baseline |
| Medical Outcome Survey-Short form (SF-36) | self-report with subscales measuring physical functioning, physical role functioning, social functioning, etc. | Change from Baseline at 6 months and 12 months after the PET visit |
| Perceived Stress Scale (PSS) | self-report measure of stress levels | Change from Baseline at 6 months and 12 months after the PET visit |
| Positive and Negative Affect Schedule (PANAS) | self-report measure of positive and negative affect | Baseline |
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | self-report measure of satisfaction and enjoyment across domains (e.g., work, leisure, social relations) | Change from Baseline at 6 months and 12 months after the PET visit |
| Snaith Hamilton Pleasure Scale (SHAPS) | self-report measure of pleasure | Change from Baseline at 6 months and 12 months after the PET visit |
| Thought and Feeling Questionnaire (TFQ) | self-report measure of perception of being stuck in difficult situations | Baseline |
| Defeat Scale (DS) | self-report measure of perception of defeat | Baseline |
| Questionnaire of Unpredictability in Childhood (QUIC) | self-report measure of unpredictability of parental environment growing up | Change from Baseline at 6 months and 12 months after the PET visit |
| Mood and Anxiety Symptom Questionnaire (MASQ) | self-report measure of mood symptom severity including 4 subscales related to depression and anxiety | Baseline |
| State-Trait Anxiety Inventory (STAI) | Measures and differentiates between anxiety | Baseline |
| PRT Post-task Questionnaire | self-report measure of participants' thoughts regarding the PRT task stimuli | Baseline |
| Temporal Experience of Pleasure Scale (TEPS) | self-report measure of ability to want and enjoy rewards | Change from Baseline at 6 months and 12 months after the PET visit |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | clinical measure of suicidality | Baseline |
| Hamilton-Depression Rating Scale (HAMD-17) | clinical measure of depression severity | Change from Baseline at 6 months and 12 months after the PET visit |
| Quick Inventory of Depressive Symptomatology (QIDS) | clinical measure of depression severity | Change from Baseline at 6 months and 12 months after the PET visit |
| Cognitive-Behavioral Avoidance Scale (CBAS) | self-report measure of trait avoidance | Baseline |
| Stress and Adversity Inventory (STRAIN) | self-report measure of lifetime exposure to acute and chronic stress that may affect mental and physical health | Change from Baseline at 12 months after the PET visit |