Major Depressive Disorder, Anxiety DisorderNCT02690324
The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders
A study testing cognitive stress (serial 7) in people with Major Depressive Disorder, Anxiety Disorder, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
development of skin adhesive patches for the monitoring and prediction of mental disorders Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Anxiety Disorder
- What is being tested?
- cognitive stress (serial 7)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, 135710
Hong Jin Jeon, MD, PhD, 82-10-3198-3586, jhj001001@gmail.com
About this study
development of skin adhesive patches for the monitoring and prediction of mental disorders
- Being tested
- cognitive stress (serial 7)
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive stress (serial 7)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Major depressive disorder | Experimental | DSM-5 major depressive disorder HAMD-17 > 16 Receives: Behavioral: cognitive stress (serial 7) |
| panic disorder | Active comparator | DSM-5 panic disorder PDSS>7 Receives: Behavioral: cognitive stress (serial 7) |
| normal control | Active comparator | age >20, healthy adults HAMD-17<17 PDSS<7 Receives: Behavioral: cognitive stress (serial 7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrodermal activity(EDA)
changes of skin conductane level(SCL) and skin conductance response(SCR)
Measured: baseline, 0.5, 1,2,3 months
Heart rate variability
changes of SDNN, RMSSD and LF/HF ratio
Measured: baseline, 0.5, 1,2,3 months
Secondary outcomes (19)
Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met
Measured: 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
Measured: baseline, 0.5, 1,2,3 months
Leptin
Measured: baseline, 0.5, 1,2,3 months
Adiponectin
Measured: baseline, 0.5, 1,2,3 months
Epinephrine
Measured: baseline, 0.5, 1,2,3 months
Norepinephrine
Measured: baseline, 0.5, 1,2,3 months
C reactive protein
Measured: baseline, 0.5, 1,2,3 months
BDNF
serum, plasma, platelet BDNF
Measured: 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)
Measured: Baseline
MINI Suicidality Module
assess current and past Axis I diagnoses
Measured: baseline, 0.5, 1,2,3 months
Hamilton Depression Rating Scale-17(HAMD-17)
changes of HAMD-17 total socres
Measured: baseline, 0.5, 1,2,3 months
Hamilton Anxiety Rating Scale(HAMA)
changes of HAMA total scores
Measured: 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).
Measured: 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.
Measured: 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)
Measured: baseline, 0.5, 1,2,3 months
SRI(Stress response Inventory)
emotional, somatic, cognitive, and behavioral stress responses.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 0.5, 1,2,3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder, Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690324
- Sponsor's protocol ID
- 2015-07-151
- Status last verified
- Nov 2015
- First submitted
- 11 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Skin Adhesive Patches for the Monitoring and Prediction of Mental Disorders
- ClinicalTrials.gov ID
- NCT02690324
- Acronym / sponsor ID
- 2015-07-151
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2018 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
development of skin adhesive patches for the monitoring and prediction of mental disorders
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Major depressive disorder | Experimental | Behavioral: cognitive stress (serial 7)DSM-5 major depressive disorder HAMD-17 > 16 |
| panic disorder | Active comparator | Behavioral: cognitive stress (serial 7)DSM-5 panic disorder PDSS>7 |
| normal control | Active comparator | Behavioral: cognitive stress (serial 7)age >20, healthy adults HAMD-17<17 PDSS<7 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive stress (serial 7) | Behavioural | Major depressive disorder, normal control, panic disorder |
Primary outcome
Electrodermal activity(EDA)
Time frame: baseline, 0.5, 1,2,3 months
changes of skin conductane level(SCL) and skin conductance response(SCR)
Heart rate variability
Time frame: baseline, 0.5, 1,2,3 months
changes of SDNN, RMSSD and LF/HF ratio
19 secondary outcomes
Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met
Time frame: baseline, 0.5, 1,2,3 months
Cytokines
Time frame: baseline, 0.5, 1,2,3 months
Leptin
Time frame: baseline, 0.5, 1,2,3 months
Adiponectin
Time frame: baseline, 0.5, 1,2,3 months
Epinephrine
Time frame: baseline, 0.5, 1,2,3 months
Norepinephrine
Time frame: baseline, 0.5, 1,2,3 months
C reactive protein
Time frame: baseline, 0.5, 1,2,3 months
BDNF
Time frame: baseline, 0.5, 1,2,3 months
MINI plus
Time frame: Baseline
MINI Suicidality Module
Time frame: baseline, 0.5, 1,2,3 months
Hamilton Depression Rating Scale-17(HAMD-17)
Time frame: baseline, 0.5, 1,2,3 months
Hamilton Anxiety Rating Scale(HAMA)
Time frame: baseline, 0.5, 1,2,3 months
Anxiety Sensitivity Index(ASI)
Time frame: baseline, 0.5, 1,2,3 months
APPQ(Albany Panic and Phobia Questionnaire)
Time frame: baseline, 0.5, 1,2,3 months
PSWQ(Penn state worry questionnaire)
Time frame: baseline, 0.5, 1,2,3 months
SRI(Stress response Inventory)
Time frame: baseline, 0.5, 1,2,3 months
Perceived Stress Scale(PSS)
Time frame: baseline, 0.5, 1,2,3 months
Barratt Impulsivity Scale
Time frame: baseline, 0.5, 1,2,3 months
Panic disorder severity scale(PDSS)
Time frame: baseline, 0.5, 1,2,3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive stress (serial 7) in people with Major Depressive Disorder, Anxiety Disorder, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Jin Jeon, MD (82-10-3198-9586, jhj001001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrodermal activity(EDA) (time frame: baseline, 0.5, 1,2,3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.