The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders

Study Overview
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Brief Summary
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development of skin adhesive patches for the monitoring and prediction of mental disorders

Conditions
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Major Depressive Disorder, Anxiety Disorder

Intervention / Treatment
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* Behavioral: cognitive stress (serial 7)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the existence of a current Major depressive disorder or panic disorder during the screening and baseline visits, per the Mini-International Neuropsychiatric Interview (Sheehan et al., 1998) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) scored at least 16 on the HDRS-17 (Hamilton, 1960) for MDD and 7 on the Panic disorder severity scale for panic disorder patients at the baseline visits. Exclusion Criteria: Patients who had psychotic disorder (e.g., schizophrenia or delusional disorder), bipolar affective disorder,active alcohol or drug use disorder, neurological illness including significant cognitive impairment or Parkinson's disease, mental retardation, significant medical conditions, epilepsy, histories of alcohol or drug dependence, personality disorders, or brain damages patients who were at serious risk for suicide of homicide

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Major depressive disorder<br>DSM-5 major depressive disorder HAMD-17 > 16 | Behavioral: cognitive stress (serial 7)<br> <br> |
| Active Comparator: panic disorder<br>DSM-5 panic disorder PDSS>7 | Behavioral: cognitive stress (serial 7)<br> <br> |
| Active Comparator: normal control<br>age >20, healthy adults HAMD-17<17 PDSS<7 | Behavioral: cognitive stress (serial 7)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |