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

Last updated: May 31, 2023
Sponsor: Happify Inc.
Overall Status: Completed

Phase

N/A

Condition

Affective Disorders

Depression

Depression (Major/severe)

Treatment

HPDT-DA-013

Clinical Study ID

NCT05016050
HPY-HPDT-DA-013-RWE-01
  • Ages > 22
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 AnxietyDisorder
  3. Access to and willingness to use computer equipment/smartphone compatible with theproduct platform over a functional network for the study duration
  4. Currently residing in the United States

Exclusion

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, BipolarDisorder 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.

Study Design

Total Participants: 367
Treatment Group(s): 1
Primary Treatment: HPDT-DA-013
Phase:
Study Start date:
August 09, 2021
Estimated Completion Date:
April 14, 2023

Study Description

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.

Connect with a study center

  • Happify Health (Remote)

    New York, New York 10003
    United States

    Site Not Available

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