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

Samsung Medical Center logo

Samsung Medical Center

Status

Unknown

Conditions

Major Depressive Disorder, Anxiety Disorder

Treatments

Behavioral: cognitive stress (serial 7)

Study type

Interventional

Funder types

Other

Identifiers

NCT02690324
2015-07-151

Details and patient eligibility

About

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

Enrollment

80 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 3 patient groups

Major depressive disorder
Experimental group
Description:
DSM-5 major depressive disorder HAMD-17 \> 16
Treatment:
Behavioral: cognitive stress (serial 7)
panic disorder
Active Comparator group
Description:
DSM-5 panic disorder PDSS\>7
Treatment:
Behavioral: cognitive stress (serial 7)
normal control
Active Comparator group
Description:
age \>20, healthy adults HAMD-17\<17 PDSS\<7
Treatment:
Behavioral: cognitive stress (serial 7)

Trial contacts and locations

1

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Central trial contact

Hong Jin Jeon, MD

Data sourced from clinicaltrials.gov

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