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

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

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

Key Exclusion Criteria:

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

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