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

Not Applicable

Recruiting

• Conditions: Mental and behavioral disorders

• Registration Number: KCT0004102
• Lead Sponsor: Yonsei University Health System, Gangnam Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures

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