Clinical trial NCT02690324: The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder, Anxiety Disorder
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: Electrodermal activity(EDA)
timeFrame: baseline, 0.5, 1,2,3 months
measure: Heart rate variability
timeFrame: baseline, 0.5, 1,2,3 months
Secondary outcomes:
measure: Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met
timeFrame: baseline, 0.5, 1,2,3 months
measure: Cytokines
timeFrame: baseline, 0.5, 1,2,3 months
measure: Leptin
timeFrame: baseline, 0.5, 1,2,3 months
measure: Adiponectin
timeFrame: baseline, 0.5, 1,2,3 months
measure: Epinephrine
timeFrame: baseline, 0.5, 1,2,3 months
measure: Norepinephrine
timeFrame: baseline, 0.5, 1,2,3 months
measure: C reactive protein
timeFrame: baseline, 0.5, 1,2,3 months
measure: BDNF
timeFrame: baseline, 0.5, 1,2,3 months
measure: MINI plus
timeFrame: Baseline
measure: MINI Suicidality Module
timeFrame: baseline, 0.5, 1,2,3 months
measure: Hamilton Depression Rating Scale-17(HAMD-17)
timeFrame: baseline, 0.5, 1,2,3 months
measure: Hamilton Anxiety Rating Scale(HAMA)
timeFrame: baseline, 0.5, 1,2,3 months
measure: Anxiety Sensitivity Index(ASI)
timeFrame: baseline, 0.5, 1,2,3 months
measure: APPQ(Albany Panic and Phobia Questionnaire)
timeFrame: baseline, 0.5, 1,2,3 months
measure: PSWQ(Penn state worry questionnaire)
timeFrame: baseline, 0.5, 1,2,3 months
measure: SRI(Stress response Inventory)
timeFrame: baseline, 0.5, 1,2,3 months
measure: Perceived Stress Scale(PSS)
timeFrame: baseline, 0.5, 1,2,3 months
measure: Barratt Impulsivity Scale
timeFrame: baseline, 0.5, 1,2,3 months
measure: Panic disorder severity scale(PDSS)
timeFrame: baseline, 0.5, 1,2,3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Irwon-dong, Gangnam-gu
Study officials:
References: