The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders
- Conditions
- Major Depressive Disorder, Anxiety Disorder
- Interventions
- Behavioral: cognitive stress (serial 7)
- Registration Number
- NCT02690324
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
development of skin adhesive patches for the monitoring and prediction of mental disorders
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description normal control cognitive stress (serial 7) age \>20, healthy adults HAMD-17\<17 PDSS\<7 Major depressive disorder cognitive stress (serial 7) DSM-5 major depressive disorder HAMD-17 \> 16 panic disorder cognitive stress (serial 7) DSM-5 panic disorder PDSS\>7
- Primary Outcome Measures
Name Time Method Electrodermal activity(EDA) baseline, 0.5, 1,2,3 months changes of skin conductane level(SCL) and skin conductance response(SCR)
Heart rate variability baseline, 0.5, 1,2,3 months changes of SDNN, RMSSD and LF/HF ratio
- Secondary Outcome Measures
Name Time Method Leptin baseline, 0.5, 1,2,3 months Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met baseline, 0.5, 1,2,3 months Adiponectin baseline, 0.5, 1,2,3 months APPQ(Albany Panic and Phobia Questionnaire) baseline, 0.5, 1,2,3 months 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.
Panic disorder severity scale(PDSS) baseline, 0.5, 1,2,3 months 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.
Cytokines baseline, 0.5, 1,2,3 months IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12(p70), IFN-γ, TNF-α
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 Hamilton Depression Rating Scale-17(HAMD-17) baseline, 0.5, 1,2,3 months changes of HAMD-17 total socres
BDNF baseline, 0.5, 1,2,3 months serum, plasma, platelet BDNF
MINI plus Baseline 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)
MINI Suicidality Module baseline, 0.5, 1,2,3 months assess current and past Axis I diagnoses
Anxiety Sensitivity Index(ASI) baseline, 0.5, 1,2,3 months 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).
Hamilton Anxiety Rating Scale(HAMA) baseline, 0.5, 1,2,3 months changes of HAMA total scores
PSWQ(Penn state worry questionnaire) baseline, 0.5, 1,2,3 months 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)
SRI(Stress response Inventory) baseline, 0.5, 1,2,3 months emotional, somatic, cognitive, and behavioral stress responses.
Perceived Stress Scale(PSS) baseline, 0.5, 1,2,3 months 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.
Barratt Impulsivity Scale baseline, 0.5, 1,2,3 months 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.
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of