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

development of skin adhesive patches for the monitoring and prediction of mental disorders

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder, Anxiety Disorder
• Intervention / Treatment: Behavioral: cognitive stress (serial 7)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Irwon-dong, Gangnam-gu
    • Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of, 135710
      • Recruiting
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major
• Other Study ID Numbers: 2015-07-151