Status:
COMPLETED
Efficacy of Clinical Application of Transcranial Low Intensity Focused Ultrasonic Stimulation for Patients With Major Deperessive Disorder - Exploratory Clinical Trial
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Major Depressive Disorder(MDD)
Eligibility:
All Genders
19-60 years
Phase:
PHASE3
Brief Summary
The non-invasive type ultrasonography system is applied to patients with major depressive disorder to evaluate their effectiveness and safety. Brain Computer Tomography(CT) and Magnetic Resonance Imag...
Eligibility Criteria
Inclusion
- 1)19 to 60 years of age 2)Having major depressive disorder without psychotic feature according to the DSM-5 diagnosis criteria SCID-5-CV: (ICD-10 code : F32.0, F32.1, F32.2, F33.0, F33.1, F33.2) 3)Montgomery-Asberg Depression Rating Scale (MADRS) score ≥12 4)No history of suicidal attempt with suicidal ideation tendency score assessed by the Scale for Suicide Ideation (SSI) ≤ 9 5)No antidepressants regimen for 4 weeks prior to enrollment. 6)n the case of active antidepressants regimen, patients with MADRS score ≥12 and who will not change their medication doses during the study period
Exclusion
- Incompatibility with brain CT and MRI
- Disorders that may cause depression (e.g., thyroid dysfunction, uncontrolled diabetes) or who taking medications that can influence on mood (e.g., thyroid hormones, steroids.)
- History of epileptic seizures
- History of major psychiatric disorder including schizophrenia and bipolar disorder
- Mental retardation
- Severe physical illness including cancer and tuberculosis
- Significant skin problems including contact dermatitis
- Pregnant women or women planning to become pregnant
- (After CT scan) skull thickness ≥ 8, or significant calcification
- (After MRI scan) structural abnormalities such as brain tumors, hemorrhage, traumatic brain disease, or structural changes due to degenerative brain disorders
Key Trial Info
Start Date :
June 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04405791
Start Date
June 12 2019
End Date
March 19 2021
Last Update
March 17 2022
Active Locations (1)
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1
GangnamSeverance Hospital
Seoul, Gangnam, South Korea