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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Major Depressive Disorder, Generalized Anxiety Disorder

Intervention / Treatment
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* Device: HPDT-DA-013


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital therapeutic<br>Use HPDT-DA-013 digital therapeutic for a period of 8-10 weeks. | Device: HPDT-DA-013<br>* Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) | A 9-item self-report measure to assess symptoms of depression | baseline to end of treatment (8-10 weeks) | 
| Generalized Anxiety Disorder-7 (GAD-7) | A 7-item self-report measure to assess symptoms of anxiety | baseline to end of treatment (8-10 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-9 | A 9-item self-report measure to assess symptoms of depression | Through study completion, average of 14 months | 
| GAD-7 | A 7-item self-report measure to assess symptoms of anxiety | Through study completion, average of 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, anxiety