Back to resultsThe Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders
Primary Purpose
Major Depressive Disorder, Anxiety Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cognitive stress (serial 7)
Sponsored by
About this trial
This is an interventional diagnostic trial for Major Depressive Disorder, Anxiety Disorder
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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Major depressive disorder
panic disorder
normal control
Arm Description
DSM-5 major depressive disorder HAMD-17 > 16
DSM-5 panic disorder PDSS>7
age >20, healthy adults HAMD-17<17 PDSS<7
Outcomes
Primary Outcome Measures
Electrodermal activity(EDA)
changes of skin conductane level(SCL) and skin conductance response(SCR)
Heart rate variability
changes of SDNN, RMSSD and LF/HF ratio
Secondary Outcome Measures
Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met
Cytokines
IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12(p70), IFN-γ, TNF-α
Leptin
Adiponectin
Epinephrine
Norepinephrine
C reactive protein
BDNF
serum, plasma, platelet BDNF
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)
MINI Suicidality Module
assess current and past Axis I diagnoses
Hamilton Depression Rating Scale-17(HAMD-17)
changes of HAMD-17 total socres
Hamilton Anxiety Rating Scale(HAMA)
changes of HAMA total scores
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).
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.
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)
SRI(Stress response Inventory)
emotional, somatic, cognitive, and behavioral stress responses.
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.
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.
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.
Full Information
NCT ID
NCT02690324
First Posted
February 11, 2016
Last Updated
February 18, 2016
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02690324
Brief Title
The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
Brief Summary
development of skin adhesive patches for the monitoring and prediction of mental disorders
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Anxiety Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Major depressive disorder
Arm Type
Experimental
Arm Description
DSM-5 major depressive disorder HAMD-17 > 16
Arm Title
panic disorder
Arm Type
Active Comparator
Arm Description
DSM-5 panic disorder PDSS>7
Arm Title
normal control
Arm Type
Active Comparator
Arm Description
age >20, healthy adults HAMD-17<17 PDSS<7
Intervention Type
Behavioral
Intervention Name(s)
cognitive stress (serial 7)
Primary Outcome Measure Information:
Title
Electrodermal activity(EDA)
Description
changes of skin conductane level(SCL) and skin conductance response(SCR)
Time Frame
baseline, 0.5, 1,2,3 months
Title
Heart rate variability
Description
changes of SDNN, RMSSD and LF/HF ratio
Time Frame
baseline, 0.5, 1,2,3 months
Secondary Outcome Measure Information:
Title
Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met
Time Frame
baseline, 0.5, 1,2,3 months
Title
Cytokines
Description
IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12(p70), IFN-γ, TNF-α
Time Frame
baseline, 0.5, 1,2,3 months
Title
Leptin
Time Frame
baseline, 0.5, 1,2,3 months
Title
Adiponectin
Time Frame
baseline, 0.5, 1,2,3 months
Title
Epinephrine
Time Frame
baseline, 0.5, 1,2,3 months
Title
Norepinephrine
Time Frame
baseline, 0.5, 1,2,3 months
Title
C reactive protein
Time Frame
baseline, 0.5, 1,2,3 months
Title
BDNF
Description
serum, plasma, platelet BDNF
Time Frame
baseline, 0.5, 1,2,3 months
Title
MINI plus
Description
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)
Time Frame
Baseline
Title
MINI Suicidality Module
Description
assess current and past Axis I diagnoses
Time Frame
baseline, 0.5, 1,2,3 months
Title
Hamilton Depression Rating Scale-17(HAMD-17)
Description
changes of HAMD-17 total socres
Time Frame
baseline, 0.5, 1,2,3 months
Title
Hamilton Anxiety Rating Scale(HAMA)
Description
changes of HAMA total scores
Time Frame
baseline, 0.5, 1,2,3 months
Title
Anxiety Sensitivity Index(ASI)
Description
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).
Time Frame
baseline, 0.5, 1,2,3 months
Title
APPQ(Albany Panic and Phobia Questionnaire)
Description
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.
Time Frame
baseline, 0.5, 1,2,3 months
Title
PSWQ(Penn state worry questionnaire)
Description
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)
Time Frame
baseline, 0.5, 1,2,3 months
Title
SRI(Stress response Inventory)
Description
emotional, somatic, cognitive, and behavioral stress responses.
Time Frame
baseline, 0.5, 1,2,3 months
Title
Perceived Stress Scale(PSS)
Description
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.
Time Frame
baseline, 0.5, 1,2,3 months
Title
Barratt Impulsivity Scale
Description
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.
Time Frame
baseline, 0.5, 1,2,3 months
Title
Panic disorder severity scale(PDSS)
Description
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.
Time Frame
baseline, 0.5, 1,2,3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Jin Jeon, MD
Phone
82-10-3198-9586
Email
jhj001001@gmail.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Irwon-dong, Gangnam-gu
ZIP/Postal Code
135710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Jin Jeon, MD, PhD
Phone
82-10-3198-3586
Email
jhj001001@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders
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