MedPath

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

Not Applicable
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
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.
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
normal controlcognitive stress (serial 7)age \>20, healthy adults HAMD-17\<17 PDSS\<7
Major depressive disordercognitive stress (serial 7)DSM-5 major depressive disorder HAMD-17 \> 16
panic disordercognitive stress (serial 7)DSM-5 panic disorder PDSS\>7
Primary Outcome Measures
NameTimeMethod
Electrodermal activity(EDA)baseline, 0.5, 1,2,3 months

changes of skin conductane level(SCL) and skin conductance response(SCR)

Heart rate variabilitybaseline, 0.5, 1,2,3 months

changes of SDNN, RMSSD and LF/HF ratio

Secondary Outcome Measures
NameTimeMethod
Leptinbaseline, 0.5, 1,2,3 months
Brain-derived neurotrophic factor(BDNF) genotyping: Val66Metbaseline, 0.5, 1,2,3 months
Adiponectinbaseline, 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.

Cytokinesbaseline, 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

Epinephrinebaseline, 0.5, 1,2,3 months
Norepinephrinebaseline, 0.5, 1,2,3 months
C reactive proteinbaseline, 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

BDNFbaseline, 0.5, 1,2,3 months

serum, plasma, platelet BDNF

MINI plusBaseline

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 Modulebaseline, 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 Scalebaseline, 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

© Copyright 2025. All Rights Reserved by MedPath