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Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder

Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder

Non Recruiting
19 years and older
All
Phase N/A

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Overview

The investigators propose to develop and adapt 'ANZEILAX' smartphone app specifically for individuals with Generalized anxiety disorder. The study will measure the therapeutic effects and safety of 'ANZEILAX' on symptoms of anxiety using pre- and post-treatment scores for generalized anxiety disorder and other physical, emotional, and cognitive symptoms of anxiety

Eligibility

Inclusion Criteria:

People can participate in this clinical trial only if following criteria are met.

  1. Adults aged 19 years or older with a high school diploma or higher
  2. Disease groups according to the criteria below:
    • A person diagnosed with Generalized Anxiety Disorder (DSM-5 (ICD-10) code: 300.02 (F41.1))
    • Those who are classified as moderate or severe with 10 points or more through GAD-7
    • Those taking prescription drugs related to generalized anxiety disorder
  3. A group of disorders with generalized anxiety disorder, or a group of disorders with

    worry that is a major symptom of generalized anxiety disorder in any of the following

    criteria
    • Those suffering from other anxiety disorders such as panic disorder and social anxiety disorder
    • Those suffering from major depressive disorder accompanied by worry, the main symptom of generalized anxiety disorder
  4. A person who fully understands the purpose, contents, and process of the clinical

    trial, agrees to participate, and signs the consent form in handwriting

Exclusion Criteria:

        If any of the following criteria is applicable, the person cannot participate in this
        clinical trial.
          1. Those who cannot read the consent form
          2. Those who are inexperienced in using smartphones
          3. In case of psychiatric symptoms or history (including schizophrenia, psychosis,
             bipolar disorder, epilepsy)
          4. In case of brain damage, cognitive impairment, or neurological disease
          5. In case of intellectual disability
          6. Having a substance and alcohol use disorder
          7. Suicidal intent, suicidal ideation, or self-injurious behavior in the past 6 months
          8. Receiving cognitive behavioral therapy for anxiety, depression or mood disorders, or
             participating in such therapy in the past 3 months
          9. Those who are registered in other clinical studies
         10. Other investigators judged that the conduct of this clinical trial was inappropriate

Study details
    Generalized Anxiety Disorder

NCT06010654

HAII corp.ltd

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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