Digital Therapeutic for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)

A Real-World Evidence, Single-Arm, Open-Label Study Evaluating the Safety and Efficacy of HPDT-DA-013 Digital Therapeutic in the Treatment of Major Depressive Disorder(MDD)and Generalized Anxiety Disorder(GAD)

Participants with Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) will use a prescribed digital therapeutic for 8-10 weeks, and will complete depression and anxiety measures during this time. After the treatment period, participants will be followed monthly for 12 months.

This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older with MDD or GAD. Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants complete PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires. After 8-10 weeks, participants will complete end-of-treatment assessments, and access to HPDT-DA-013 will be removed. Participants are then followed for a period of 12 months.

Inclusion Criteria:

1. Adults 22 years or older at the time of screening
2. Meets DSM-5 diagnostic criteria for Major Depressive Disorder or Generalized Anxiety Disorder
3. Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration
4. Currently residing in the United States

Key Exclusion Criteria:

1. Risk of suicide or has attempted suicide within 24 months of the screening visit
2. Moderate to severe substance use disorder
3. Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, or Borderline Personality Disorder
4. Currently pregnant or planning to become pregnant during the treatment period

Note: Other protocol-defined inclusion/exclusion criteria applied.