se of Artificial Intelligence based medical technology for screening anxiety and depressio
Not Applicable
- Conditions
- Health Condition 1: F411- Generalized anxiety disorder
- Registration Number
- CTRI/2023/07/054984
- Lead Sponsor
- TerraBlue XT(P) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Subject is willing and able to give informed consent for participation in the study.
2.Subjects with DSM 5 clinical diagnosis of unipolar depression mood and GAD
3.Severity of anxiety and depression confirmed by PHQ-9 and GAD-7.
4.Male or Female of age 18 â?? 60 years
Exclusion Criteria
1.Subjects with other psychotic disorders
2.Any neurological disorders such as any significant head injury, epilepsy, Parkinsonâ??s disease, neuro-degenerative disorders etc.
3.Subjects of substance use disorders
4.Pregnant and lactating women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To validate the AI powered wearable device algorithm for detecting Generalized Anxiety Disorder (GAD) and Depressive Disorder (unipolar and recurrent depressive disorder) with a minimum acceptable sensitivity rate of 80% and specificity rate of 70 %.Timepoint: Screening or Baseline Visit
- Secondary Outcome Measures
Name Time Method To validate whether technology can be used reliably for screening of common mental health disorders, like anxiety and depressionTimepoint: Screening or Baseline Visit