NCT07792252Not yet recruiting
REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness
A Prospective Observational Real-World Evidence Study of a 510(k)-Cleared Prescription Digital Therapeutic in Patients Receiving Interventional Treatment for Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
Rejoyn is a Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD). This study aims to evaluate the feasibility, engagement, and clinical context of integrating Rejoyn into standard interventional workflows at the Yale New Haven Hospital Interventional Psychiatry Service (IPS). This is a non-significant risk, observational real-world evidence (RWE) study.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Yale University
- Diseases
- Depression
- NCT number
- NCT07792252
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Sept 2026 to the primary completion date, 31 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another interventional study that would interfere with naturalistic data
Other illness
- Significant cognitive impairment that prevents app use
Other
- Clinician determines Rejoyn is not suitable or safe for the patient
- Insufficient English proficiency to use Rejoyn
Who the study is looking for
- Clinician-confirmed diagnosis of Major Depressive Disorder
- Currently being treated with an antidepressant medication
- Currently receiving or initiating TMS or esketamine at YNHH IPS
- For those receiving TMS, they must be able to initiate Rejoyn within the first two weeks of beginning TMS
- Experiencing at least mild depressive symptoms as defined by QIDS of ≥6
- Clinician determines patient is appropriate for Rejoyn and prescribes it as part of standard care
- Able to access and use a compatible smartphone
- Able to provide informed consent for use of clinical data in research
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale Greenwich Hospital Interventional Psychiatry Services Coordinator of this site? Confirm its status | Greenwich | United States | Unknown status |
| Yale New Haven Hospital Interventional Psychiatry Services Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.