A single-arm, multicenter, prospective investigator-initiated exploratory clinical trial to investigate the therapeutic effects of ‘ANZEILAX' in managing anxiety disorders not otherwise specified

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010215

Enrollment

Registered

2025-02-21

Start date

2025-02-03

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This exploratory clinical trial will conduct screening for participants who have voluntarily provided written informed consent. Participants who pass the screening will be provided wi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals aged 13 to 39 who are diagnosed with unspecified anxiety disorder (ICD-10 code: F41.9). 2. Individuals with a score of 8 or higher on the Beck Anxiety Inventory (BAI), indicating mild anxiety or greater. 3. Individuals who fully understood the purpose, content, and process of the clinical trial and have provided written informed consent with their signature. 4. Individuals who have not had any changes in psychiatric medication from 30 days prior to the screening date until the present.

Exclusion criteria

Exclusion criteria: 1. Individuals who are unable to read the informed consent form. 2. Individuals who are not proficient in using a smartphone. 3. Individuals under treatment for major psychiatric disorders such as severe depressive disorder requiring hospitalization, suicidal tendencies, bipolar disorder, or schizophrenia. 4. Individuals with neurological disorders such as brain injury, epilepsy, or cognitive impairment. 5. Individuals with intellectual disabilities. 6. Individuals with substance use disorders or alcohol use disorders. 7. Individuals who have exhibited suicidal intent, suicidal impulses, or self-harming behaviors within the past 6 months. 8. Individuals who are currently receiving or have received cognitive-behavioral therapy (CBT) for anxiety, depression, or mood disorders within the past 6 months. 9. Individuals who are enrolled in other clinical trials. 10. Individuals who are deemed unsuitable for participation in this clinical trial at the discretion of the investigator.

Design outcomes

Primary

Measure	Time frame
Generalized Anxiety Disorder 7-item(GAD-7);Patient Health Questionnaire-9(PHQ-9);Hamilton Anxiety Rating Scale(HAM-A);Clinical Global Impression(CGI-I, S);Pittsburgh Sleep Quality Index(PSQI);Rosenberg Self Esteem Scale(RSES);adherence assessment;satisfaction assessment	—

Secondary

Measure	Time frame
evaluation of adverse device effects	—

Countries

Korea, Republic of

Contacts

Public ContactSung Ah Chung

Chung-Ang Univerisity Hospital

agnes@cauhs.or.kr+82-2-6299-1508

Outcome results