None listed
Conditions
Interventions
Medical Device : In the active treatment group, participants receive real ultrasound stimulation targeted to the left dorsolateral prefrontal cortex. The procedure uses a low-intensity focused ultraso
instead, the device produces only sound and vibration to mimic stimulation. Participants and investigators cannot distinguish between real and sham treatment, ensuring double-blinding for unbiased ass
Sponsors
Neurosona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged 19 years or older and under 65 years 2. Patients diagnosed with Major Depressive Disorder without psychotic features according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria, corresponding to the following International Classification of Diseases, 10th Revision codes: F32.0, F32.1, F32.2, F33.0, F33.1, F33.2 i. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnostic criteria for Major Depressive Disorder (five or more of the following nine symptoms must be present during the same 2-week period; at least one of symptom ? or ? is required): ? Persistent depressed mood ? Markedly diminished interest or pleasure in all, or almost all, daily activities ? Significant weight loss or weight gain when not dieting ? Insomnia or hypersomnia ? Psychomotor agitation or retardation ? Fatigue or loss of energy ? Feelings of worthlessness or excessive/inappropriate guilt ? Diminished ability to think or concentrate, or indecisiveness (either subjective or observed by others) ? Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or specific plan for committing suicide ii. International Classification of Diseases, 10th Revision codes must correspond to: - F32.0: Mild depressive episode - F32.1: Moderate depressive episode - F32.2: Severe depressive episode without psychotic symptoms - F33.0: Recurrent depressive disorder, current episode mild - F33.1: Recurrent depressive disorder, current episode moderate - F33.2: Recurrent depressive disorder, current episode severe without psychotic symptoms 3. Patients who have a Montgomery-Åsberg Depression Rating Scale score of 12 or higher i. The Montgomery-Åsberg Depression Rating Scale consists of 10 items assessing depressive symptoms, each rated on a 7-point Likert scale ranging from 0 to 6. A higher total score indicates more severe depression. A score of 12 or above is considered indicative of depressive disorder. 4. Patients with no history of suicide attempts and a score of 9 or lower on the suicidality assessment using the Mini International Neuropsychiatric Interview, Module C 5. Patients who have not taken antidepressants from 4 weeks prior to study participation through the end of the trial (final follow-up), and who do not receive any additional therapeutic interventions (e.g., electroconvulsive therapy, transcranial magnetic stimulation) outside the investigational medical device 6. Patients who have not undergone a computed tomography scan within the past year, or if they have, must have received a radiologist’s opinion that the potential risks of an additional computed tomography scan do not outweigh the expected clinical benefits of study participation
Exclusion criteria
Exclusion criteria: 1. Individuals who are unable to undergo brain computed tomography or brain magnetic resonance imaging 2. Individuals with any of the following findings on brain computed tomography: - Skull thickness of 10 millimeters or more - Clinically significant intracranial calcification - Evidence of meningioma, brain tumor, abscess, fluid retention, hydrocephalus, ischemic brain injury (for example, stroke), trauma, skull fracture, or congenital brain malformation 3. Individuals with any of the following abnormalities observed on brain magnetic resonance imaging: - Brain tumor, intracranial hemorrhage, traumatic brain injury, or degenerative brain diseases such as cortical atrophy 4. Individuals with a history of brain surgery, head injury, or cranial trauma 5. Individuals with medical conditions that may cause depressive symptoms (including internal medical diseases, cardiovascular diseases, neurological disorders, or endocrine disorders) or individuals currently taking medications that may affect mood (e.g., thyroid hormones, steroids, etc). 1) Internal diseases: liver cancer, liver cirrhosis 2) Cardiac diseases: heart failure, ischemic heart disease, cardiovascular disease 3) Neurological diseases: stroke, epilepsy 4) Endocrine disorders: thyroid dysfunction 6. Individuals with metallic implanted medical devices or external medical attachments (for example, cardiac pacemakers, neurostimulators) 7. Individuals with a history of epileptic seizures 8. Individuals diagnosed with major comorbid psychiatric disorders such as schizophrenia or bipolar disorder - As assessed by the Mini International Neuropsychiatric Interview - Individuals scoring 7 or more on the Mood Disorder Questionnaire will also be excluded 9. Individuals with a history of alcohol or substance dependence 10. Individuals suspected of having intellectual disability - Defined as a score below 70 on the short-form intelligence test 11. Individuals with severe physical illnesses (for example, cancer, tuberculosis) 12. Individuals with sensitive skin conditions, including contact dermatitis 13. Pregnant women or women who are planning to become pregnant 14. Individuals who are illiterate or non-Korean-speaking foreigners who are unable to read the informed consent document
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with = 50% reduction in Montgomery-Asberg Depression Scale total score from baseline;Adverse event frequency - severity - causality | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score;Remission rate based on Montgomery-Åsberg Depression Rating Scale;Change in Quick Inventory of Depressive Symptomatology–Self Report (QIDS-SR) and Korean version of the Profile of Mood States (K-POMS);Change in Scale for Suicidal Ideation (SSI) score;Change in State-Trait Anxiety Inventory (STAI) score;Change in heart rate variability (HRV);Change in functional connectivity measured by resting-state functional magnetic resonance imaging (resting-state fMRI);Incidence of adverse events by type (detailed analysis by treatment session and follow-up visit);Treatment compliance (number of completed sessions out of 6 total sessions) | — |
Countries
Korea, Republic of
Contacts
Public ContactWoo Yeonjae
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed