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)

  • End date
    Apr 22, 2024
  • participants needed
  • sponsor
    Happify Inc.
Updated on 22 September 2022


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.

Condition Major Depressive Disorder, Generalized Anxiety Disorder
Treatment HPDT-DA-013
Clinical Study IdentifierNCT05016050
SponsorHappify Inc.
Last Modified on22 September 2022


Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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