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development of skin adhesive patches for the monitoring and prediction of mental disorders
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major depressive disorder | Experimental | DSM-5 major depressive disorder HAMD-17 > 16 |
|
| panic disorder | Active Comparator | DSM-5 panic disorder PDSS>7 |
|
| normal control | Active Comparator | age >20, healthy adults HAMD-17<17 PDSS<7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive stress (serial 7) | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electrodermal activity(EDA) | changes of skin conductane level(SCL) and skin conductance response(SCR) | baseline, 0.5, 1,2,3 months |
| Heart rate variability | changes of SDNN, RMSSD and LF/HF ratio | baseline, 0.5, 1,2,3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met | baseline, 0.5, 1,2,3 months | |
| Cytokines | IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12(p70), IFN-γ, TNF-α | baseline, 0.5, 1,2,3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Jin Jeon, MD | Contact | 82-10-3198-9586 | jhj001001@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Irwon-dong, Gangnam-gu | 135710 | South Korea |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Leptin | baseline, 0.5, 1,2,3 months |
| Adiponectin | baseline, 0.5, 1,2,3 months |
| Epinephrine | baseline, 0.5, 1,2,3 months |
| Norepinephrine | baseline, 0.5, 1,2,3 months |
| C reactive protein | baseline, 0.5, 1,2,3 months |
| BDNF | serum, plasma, platelet BDNF | baseline, 0.5, 1,2,3 months |
| MINI plus | structured interview assessing for DSM-IV Axis I disorders with strong reliability and validity in relation to the Structured Clinical Interview for DSM-IV (SCID-IV) | Baseline |
| MINI Suicidality Module | assess current and past Axis I diagnoses | baseline, 0.5, 1,2,3 months |
| Hamilton Depression Rating Scale-17(HAMD-17) | changes of HAMD-17 total socres | baseline, 0.5, 1,2,3 months |
| Hamilton Anxiety Rating Scale(HAMA) | changes of HAMA total scores | baseline, 0.5, 1,2,3 months |
| Anxiety Sensitivity Index(ASI) | ASI-3 to measure the three most supported AS domains: social (i.e., fear of exhibiting symptoms in public that may elicit embarrassment), cognitive (i.e., fear of losing cognitive control or experiencing concentration difficulties), and physical (i.e., fear that physical sensations are a sign of an immediate physical problem). | baseline, 0.5, 1,2,3 months |
| APPQ(Albany Panic and Phobia Questionnaire) | The APPQ (Rapee et al., 1995) is a 27-item instrument that is designed to measure interoceptive, agoraphobic, and social situational fear. Subjects respond to each item on a 9-point Likert scale from 0 to 8, according to how much fear they think they would experience in a given situation so that total scores range from 0 to 216. | baseline, 0.5, 1,2,3 months |
| PSWQ(Penn state worry questionnaire) | 16-item questionnaire that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me) | baseline, 0.5, 1,2,3 months |
| SRI(Stress response Inventory) | emotional, somatic, cognitive, and behavioral stress responses. | baseline, 0.5, 1,2,3 months |
| Perceived Stress Scale(PSS) | The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. | baseline, 0.5, 1,2,3 months |
| Barratt Impulsivity Scale | The Barratt Impulsiveness Scale (BIS) is a widely used measure of impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness).The BIS-11 is a 30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. | baseline, 0.5, 1,2,3 months |
| Panic disorder severity scale(PDSS) | The items assess panic frequency, distress during panic, panic-focused anticipatory anxiety, phobic avoidance of situations, phobic avoidance of physical sensations, impairment in work functioning, and impairment in social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. The total scores range from 0 to 28. | baseline, 0.5, 1,2,3 months |