An Exploratory Clinical Study for Verifying the Treatment Efficacy of Noninvasive Ultrasound Stimulation System for Depression

Efficacy of Clinical Application of Transcranial Low Intensity Focused Ultrasound Stimulation for Patients with Major Depressive Disorder - Exploratory Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0004102

Enrollment

Registered

2019-06-28

Start date

2019-06-21

Completion date

Unknown

Last updated

2019-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The subjects were selected from the group of patients aged 19 to 60 years who were diagnosed with major depressive disorder without psychotic symptoms (ICD-10 code: F32.0, F32.1, F32.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Montgomery-Asberg Depression Rating Scale (MADRS) score of 12 or more 2) Patients who did not start medication or who maintained a MADRS score of 20 points or more for antidepressant treatment for 4 weeks or more

Exclusion criteria

Exclusion criteria: 1) Patients who can not undergo Brain CT and MRI 2) Brain CT showed a skull thickness of more than 8 mm or a clinically significant calcification 3) Patients with structural abnormalities such as brain tumors, cerebral hemorrhage, traumatic brain disease, or changes due to degenerative brain disease in MRI 4) Patients with physical illnesses that may cause depressive symptoms (thyroid dysfunction, uncontrolled diabetes, etc.) or those taking medication that may cause depressive symptoms 5) Patients with a history of epileptic seizures 6) Patients with coexisting major psychiatric disorders such as schoziphrenia or bipolar disorder (identified as MINI) 7) Patients suspected of having intellectual disability (discriminated by short-form intelligence test) 8) Patients with severe physical illness (cancer, tuberculosis, etc.) 9) Persons with sensitive skin disease including contact skin dermatitis 10) Pregnant women or women planning pregnancy 11) Foreigners and illiterates who can not read the consent form

Design outcomes

Primary

Measure	Time frame
Montgomery-Asberg Depression Rating Scale	—

Secondary

Measure	Time frame
Quick Inventory of Depressive Symptomatology;Scale for Suicidal Ideation;State-Trait Anxiety Inventory;Stockings of Cambridge;Spatial working memory and Continuous Performance Test	—

Countries

Korea, Republic of

Contacts

Public ContactJin Sun Ryu

Yonsei University Health System, Gangnam Severance Hospital

deardooly@hanmail.net+82-2-2019-3340

Outcome results