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

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)

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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)