HPDT-DA-013 for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Happify Health (Remote), New York, NY
Depression+6 More
HPDT-DA-013 - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a digital therapeutic can help people with depression or anxiety.

See full description

Eligible Conditions

  • Depression
  • Major Depressive Disorder (MDD)
  • Generalized Anxiety Disorder

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether HPDT-DA-013 will improve 2 primary outcomes and 2 secondary outcomes in patients with Depression. Measurement will happen over the course of baseline to end of treatment (8-10 weeks).

Month 14
GAD-7
PHQ-9
Week 10
Generalized Anxiety Disorder-7 (GAD-7)
Patient Health Questionnaire-9 (PHQ-9)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

1 Treatment Group

Digital therapeutic
1 of 1
Experimental Treatment

This trial requires 750 total participants across 1 different treatment group

This trial involves a single treatment. HPDT-DA-013 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Digital therapeutic
Device
Use HPDT-DA-013 digital therapeutic for a period of 8-10 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, average of 14 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, average of 14 months for reporting.

Closest Location

Happify Health (Remote) - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What causes melancholia?

"There is a genetic component to major depression, and the onset of depression is often linked to a combination of biopsychosocial factors. While studies of twins suggest that hereditary factors play a role, there is a lack of evidence for single gene contribution, nor for a specific risk gene. Stressful life events and social factors may be important to the pathophysiology of depressed patients." - Anonymous Online Contributor

Unverified Answer

Can melancholia be cured?

"The remission of depression is not permanent. The clinical and therapeutic significance of the data obtained in this study (melancholia being associated with a higher risk of death) should be verified by further studies." - Anonymous Online Contributor

Unverified Answer

What are common treatments for melancholia?

"Although antidepressants and anxiolytics are effective and widely used medications to treat patients with depressive disorders, they also can be used to treat [chronic depression] (atypical depression) and depressive symptomology (symptoms that don't necessarily require treatment but can significantly affect quality of living). This is especially important for patients who also have anxiety disorders, including somatic symptoms such as fatigue, weight loss or [chronic unexplained fatigue syndrome]. [Withdrawal of antidepressants and anxiolytics from patients with persistent or [severe symptoms, including mood or anxiety] can lead to acute exacerbations of depression, and worsen the patients' overall condition." - Anonymous Online Contributor

Unverified Answer

What are the signs of melancholia?

"The symptoms of depression may be the same as other major depressive disorders. Some of the most common symptoms of depression that a person may report, may be present in other mental disorders. These symptoms may also be referred to as the core or melancholic symptoms.\n" - Anonymous Online Contributor

Unverified Answer

What is melancholia?

"Melancholia is an emotional mood disorder that often co-occurs with major depression, bipolar disorder and dysthymia. It is unclear what the cause is and how to treat the symptoms. Patients have often been labeled with the more popular diagnostic term cyclothymia." - Anonymous Online Contributor

Unverified Answer

How many people get melancholia a year in the United States?

"Based on the number of new cases of melancholia and major depression diagnosed in the past 5 years it appears that approximately 200,000 of the 750,000 cases of depression in the United States yearly are due to melancholia." - Anonymous Online Contributor

Unverified Answer

What is hpdt-da-013?

"After the drug's first year of clinical trial, people with the depression spectrum phenotype tended to have an increased incidence of the depressive disorders, but also an decreased incidence of the cognitive impairment, cognitive and language symptoms of Alzheimer's disease. Recent findings were not seen with the other phenotype groups, and thus may be explained by an interaction of the compound's effects on the depressive and cognitive and language manifestations of AD. It may also be that those with an early onset of Alzheimer's disease are more responsive to this compound's effects, compared with those with late-onset Disease. Further, patients whose depression spectrum symptoms improved showed a decrease in the incidence of dementia." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets melancholia?

"A lifetime prevalence estimate of 13% was calculated for melancholia in this adolescent population. It was found to be slightly dependent on the presence of anxiety or suicidal ideation. The median age of presentation of this disorder in the study cohort was 15, and the age range was 12–18 years. These data further support the view that the mood disorders experienced in childhood may persist into later life, and that such manifestations are in fact related to an earlier disturbance of mood." - Anonymous Online Contributor

Unverified Answer

Has hpdt-da-013 proven to be more effective than a placebo?

"Overall there were no statistically significant differences between the two experimental groups in terms of symptom improvement and remission rate. We also found similar rates of improvement in the HPDT-da-013 group in both of our primary and secondary outcomes. While this study is encouraging, further research with a longer follow-up and different populations will be needed to determine whether we can confirm these results." - Anonymous Online Contributor

Unverified Answer

How does hpdt-da-013 work?

"In summary, hpdt-da-013 is a simple, inexpensive oral formulation of a potent, selective inhibitor of PDE-4 in animal models of depression. It increases the rewarding profile of the drug itself and enhances antidepressant effect in animals. This is the first report on the potential utility of PDE-4 inhibition for improving the acute and delayed effects of antidepressants. PDE-4 inhibition may be of interest in this regard due to previously documented PDE-4 inhibition enhancement of serotonin turnover in the brain in animal models and in humans as a result of increased clearance of SSRIs." - Anonymous Online Contributor

Unverified Answer

Does hpdt-da-013 improve quality of life for those with melancholia?

"The HPDT DA-013 treatment was well tolerated by patients with melancholic depressive symptoms who had already completed the treatment regimen at St John's Hospital University in Auckland, New Zealand." - Anonymous Online Contributor

Unverified Answer

Does melancholia run in families?

"The findings suggest an independent familial background to melancholia and may be explained by linkage with chromosome 14, on which loci for temperament and character traits and schizophrenia are also found." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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