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

Major Depressive Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016050
• Other study ID #: HPY-HPDT-DA-013-RWE-01
• Status: Completed
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: April 14, 2023

Study information

• Verified date: May 2023
• Source: Happify Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: April 14, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Generalized Anxiety Disorder
• Major Depressive Disorder

Intervention

Device:
• HPDT-DA-013
Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).

Locations

Country	Name	City	State
United States	Happify Health (Remote)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Happify Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	PHQ-9	A 9-item self-report measure to assess symptoms of depression	Through study completion, average of 14 months
Secondary	GAD-7	A 7-item self-report measure to assess symptoms of anxiety	Through study completion, average of 14 months