Major Depressive DisorderNCT05016050
Digital Therapeutic for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)
A study testing HPDT-DA-013 in people with Major Depressive Disorder and Generalized Anxiety Disorder, run by Happify Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Major Depressive Disorder, Generalized Anxiety Disorder
- What is being tested?
- HPDT-DA-013
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the detailed 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.
- Being tested
- HPDT-DA-013
- Keywords
- depression, anxiety
- Medical subject headings
- Depressive Disorder, Major, Generalized Anxiety Disorder, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPDT-DA-013Device
Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).
| Study group | Role | What they receive |
|---|---|---|
| Digital therapeutic | Experimental | Use HPDT-DA-013 digital therapeutic for a period of 8-10 weeks. Receives: Device: HPDT-DA-013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report measure to assess symptoms of depression
Measured: 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
Measured: baseline to end of treatment (8-10 weeks)
Secondary outcomes (2)
PHQ-9
A 9-item self-report measure to assess symptoms of depression
Measured: Through study completion, average of 14 months
GAD-7
A 7-item self-report measure to assess symptoms of anxiety
Measured: Through study completion, average of 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start9 Aug 2021
- Primary completion16 Mar 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Happify Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Vilardaga, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016050
- Sponsor's protocol ID
- HPY-HPDT-DA-013-RWE-01
- Status last verified
- May 2023
- First submitted
- 16 Aug 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05016050
- Acronym / sponsor ID
- HPY-HPDT-DA-013-RWE-01
- Keywords
- depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Happify Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital therapeutic | Experimental | Device: HPDT-DA-013Use HPDT-DA-013 digital therapeutic for a period of 8-10 weeks. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPDT-DA-013Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT). | Device | Digital therapeutic |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline to end of treatment (8-10 weeks)
A 9-item self-report measure to assess symptoms of depression
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: baseline to end of treatment (8-10 weeks)
A 7-item self-report measure to assess symptoms of anxiety
2 secondary outcomes
PHQ-9
Time frame: Through study completion, average of 14 months
GAD-7
Time frame: Through study completion, average of 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Vilardaga, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPDT-DA-013 in people with Major Depressive Disorder and Generalized Anxiety Disorder, run by Happify Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: baseline to end of treatment (8-10 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.