Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060987) titled 'Development of EEG Data Collection, Screening, and Symptom Quantification Technology for Specific Symptoms Associated with Depression and Anxiety: A Pilot Study' on March 20.

Study Type: Observational

Primary Sponsor: Institute - Keio University

Condition: Condition - 1. Patients with depressive, anxiety, and obsessive-compulsive and related disorders 2. Healthy Controls Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This pilot study aims to collect EEG signals using a wearable EEG device from healthy individuals and patients with depressive, anxiety, and obsessive-compulsive and related disorders, specifically under conditions where certain symptoms (rumination or obsessions) are likely to occur. By visualizing the EEG characteristics associated with these symptoms, we will develop a machine learning program for future symptom quantification and neurofeedback. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - For Patients:

1. Individuals aged 18 years or older diagnosed with any of the following according to DSM-5-TR criteria: depressive disorders, anxiety disorders, or obsessive-compulsive and related disorders accompanied by rumination or obsessions.

2. Individuals currently undergoing Cognitive Behavioral Therapy (CBT) focused on rumination or Exposure and Response Prevention (ERP) with a therapist, or performing these as structured homework assignments.

3. Individuals judged by their primary physician to have the capacity to provide informed consent.

For Healthy Controls:

1. Individuals with no history of psychiatric disorders who volunteered for the study via the recruitment website.

2. Individuals aged 18 years or older at the time of providing informed consent. Key exclusion criteria - For Patients:

1. Individuals with physical conditions that interfere with EEG electrode placement or measurement (e.g., scalp dermatosis, cranial bone defects)

2. Individuals with neuropsychiatric (e.g., epilepsy, substance use disorders, organic brain disorders) or medical conditions (e.g. brain tumors, cerebral infarction, impaired consciousness, or traumatic brain injury) known to significantly affect EEG signals

3. Individuals currently undergoing treatments expected to significantly alter EEG results (e.g., Electroconvulsive Therapy [ECT], Transcranial Magnetic Stimulation [TMS], or use of anti-epileptic medications)

4. Individuals with severe suicidal ideation

5. Individuals whose primary diagnosis is a neuropsychiatric disorder other than those targeted in this study (e.g., schizophrenia)

6. Any other individuals determined by the principal investigator or sub-investigator to be unsuitable for the study

For Healthy Controls:

1. Individuals with physical conditions that interfere with EEG electrode placement or measurement (e.g., scalp dermatosis, cranial bone defects)

2. Individuals with neuropsychiatric (e.g., epilepsy, substance use disorders, organic brain disorders) or medical conditions (brain tumors, cerebral infarction, impaired consciousness, or traumatic brain injury) known to significantly affect EEG signals

3. Individuals currently undergoing treatments expected to significantly alter EEG results (e.g., ECT, TMS, or use of anti-epileptic medications)

4. Any other individuals determined by the principal investigator or sub-investigator to be unsuitable for the study Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 13 Day Date of IRB - 2026 Year 03 Month 13 Day Anticipated trial start date - 2026 Year 03 Month 25 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069724

Disclaimer: Curated by HT Syndication.