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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| pseudotreatment | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Ultrasound Stimulation | Device | Actual treatment in this group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of BDNF at 5(+4) Weeks. | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) | |
| Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of IL-1 at 5(+4) Weeks. | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) | |
| Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of IL-6 at 5(+4) Weeks. | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) | |
| Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of IL-8 at 5(+4) Weeks. | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) | |
| Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of TNF-alpha at 5(+4) Weeks. | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) | |
| Status of neurological examination | Normal or Abnormal | baseline establishment, and Week 5(+4 weeks) |
| Height in centimeters | Screening phase (4 weeks before the initiation of treatment), and Week 5(+4 weeks) | |
| Weight in kilograms | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The Positive and Negative Syndrome Scale (PANSS) | The Positive and Negative Syndrome Scale (PANSS), developed by Kay et al. in 1987, is a well-established clinical scale utilized to assess symptoms in patients with schizophrenia. The PANSS comprises 30 items categorized into three primary subscales: Positive Scale (7 items): Evaluates pathologically amplified symptoms, such as delusions and hallucinations. Negative Scale (7 items): Focuses on deficit symptoms, including blunted affect and social withdrawal. General Psychopathology Scale (16 items): Covers non-specific psychological states, such as anxiety and tension. Scoring and Clinical Application: Each item is scored on a 7-point severity scale ranging from 1 (absent) to 7 (extreme), yielding a total score between 30 and 210. Characterized by high reliability and validity, the PANSS serves as a critical tool in both clinical research and practice for measuring symptom severity, tracking therapeutic efficacy, and evaluating disease progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi-Ju Pan | Contact | +2168 886-2-8966-7000 | panyiju0211@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | Recruiting | New Taipei City | 220 | Taiwan |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Transcranial Ultrasound Stimulation |
| Device |
No actual treatment in this group |
|
| Temperature in Celsius | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) |
| Respiratory rate in breaths per minutes | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) |
| Blood pressure in mmHg | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) |
| Electrocardiogram (ECG) R-R interval | Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks) |
| baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks) |
| Clinical Global Impression (CGI) | The Clinical Global Impressions (CGI) scale is a brief, widely accepted instrument used by clinicians to rapidly evaluate psychiatric patients' symptom severity, therapeutic response, and overall efficacy based on direct observation and clinical experience. It comprises three companion subscales: CGI-Severity (CGI-S): Rates the clinician's impression of current illness severity on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). CGI-Improvement (CGI-I): Evaluates overall change relative to the baseline state on a 7-point scale, from 1 (very much improved), 4 (no change), to 7 (very much worse). CGI-Efficacy (CGI-E): Indexes both therapeutic efficacy and treatment-related side effects to gauge global clinical benefit. Due to its simplicity and independence from complex instruments, the CGI is frequently employed in clinical trials and routine practice. | baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks) |
| Hamilton Depression Rating Scale (HAMD) | The Hamilton Depression Rating Scale (HAMD), designed by Hamilton in 1960, is a clinical scale used to assess symptom severity in patients with depression. The most widely used version contains 17 items (HAMD-17). Each item is scored 0-4 or 0-2 based on severity. The HAMD-17 ranges from 0 to 52. The HAMD evaluates multiple dimensions, including mood, insomnia, appetite, anxiety, somatic symptoms, and daily functioning. Specific areas assessed include depressed mood, guilt, suicidal ideation, and changes in weight. Total scores indicate illness severity: scores below 7 are generally considered normal, while scores of 20 or higher indicate moderate-to-severe depression. Characterized by high reliability and validity, the HAMD serves as a gold-standard instrument for evaluating the efficacy of antidepressant therapies in clinical trials. | baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks) |
| Cambridge Neuropsychological Test Automated Battery (CANTAB) | The following specific subtests from the Cambridge Neuropsychological Test Automated Battery (CANTAB) will be administered, and individual scores for each task will be systematically recorded: Emotion Recognition Task (ERT): Measures social cognition and emotional processing. Multitasking Test (MTT): Evaluates executive function and cognitive flexibility. One Touch Stockings of Cambridge (OTS): Assesses spatial planning and problem-solving. Paired Associates Learning (PAL): Evaluates visual episodic memory and learning. Reaction Time (RTI): Measures motor and mental response speeds. Rapid Visual Information Processing (RVP): Assesses sustained attention. Spatial Working Memory (SWM): Evaluates working memory and strategy. Verbal Recognition Memory (VRM): Measures immediate and delayed verbal memory. | baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks) |