Major Depressive Disorder (MDD)REWIRENCT07792252
REWIRE: Real-world Engagement With Interventional and Rejoyn Effectiveness
An observational study of Major Depressive Disorder (MDD), run by Yale University at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Rejoyn and Cognitive Behavioral Therapy (CBT) exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults diagnosed with MDD who are receiving intranasal esketamine or TMS.
Who may be able to join
- 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
Who cannot join
- Clinician determines Rejoyn is not suitable or safe for the patient
- Significant cognitive impairment that prevents app use
- Insufficient English proficiency to use Rejoyn
- Concurrent participation in another interventional study that would interfere with naturalistic data
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Yale Greenwich Hospital Interventional Psychiatry Services
Greenwich, Connecticut, 06830
Yale New Haven Hospital Interventional Psychiatry Services
New Haven, Connecticut, 06519
About this study
Official title: A Prospective Observational Real-World Evidence Study of a 510(k)-Cleared Prescription Digital Therapeutic in Patients Receiving Interventional Treatment for Major Depressive Disorder
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.
Read the detailed description
This study is only recruiting internally from among established patients and does not accept external participants.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Rejoyn, Cognitive Behavioral Therapy (CBT) exercises
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RejoynDevice
Rejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment.
Cognitive Behavioral Therapy (CBT) exercisesBehavioural
Cognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review.
| Study group | Role | What they receive |
|---|---|---|
| Rejoyn in participants with Major Depressive Disorder | Rejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment. The Rejoyn program includes 6 weeks of active Emotional Faces Memory Task (EFMT) training and Cognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review. Receives: Device: Rejoyn; Behavioral: Cognitive Behavioral Therapy (CBT) exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients prescribed Rejoyn
Number of patients prescribed Rejoyn out of all eligible patients in the clinic
Measured: From screening through enrollment, approximately 1 week
Mean participant app use to assess engagement
Mean number of times app was engaged
Measured: up to Week 12
Mean duration of app use to assess engagement
Mean duration in minutes of app use
Measured: up to Week 12
Mean number lessons completed to assess engagement
Mean number lessons completed
Measured: up to Week 12
Number of participants adherent to Rejoyn
Adherence defined as completion of at least 12 of the 18 sessions
Measured: up to Week 12
Secondary outcomes (4)
Change in Montgomery Asberg Depression Rating Scale (MADRS) score
A 10-item rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed).
Measured: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
Change in Quick Inventory of Depressive Symptomatology (QIDS) score
A 16-item self-reported rating scale designed to assess severity of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depression.
Measured: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
Mean mHealth Satisfaction Questionnaire score
Satisfaction Questionnaire to assess participant satisfaction. Scores range from 1 to 5, with higher scores indicating more satisfaction.
Measured: baseline and 12-weeks
Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire
Number of clinicians who referred patients to Rejoyn that complete the Clinician Feasibility \& Workflow Questionnaire at the end of the study
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Morgan Hardy, MD, MPH, Principal investigator, Yale UniversitySongjun W Li, MD PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792252
- Sponsor's protocol ID
- 2000042722
- Acronym
- REWIRE
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Real-World Evidence Study of a 510(k)-Cleared Prescription Digital Therapeutic in Patients Receiving Interventional Treatment for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07792252
- Acronym / sponsor ID
- REWIRE / 2000042722
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Aug 2026 (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.
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.
Detailed description
This study is only recruiting internally from among established patients and does not accept external participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rejoyn in participants with Major Depressive Disorder | – | Device: Rejoyn, Behavioral: Cognitive Behavioral Therapy (CBT) exercisesRejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment. The Rejoyn program includes 6 weeks of active Emotional Faces Memory Task (EFMT) training and Cognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with MDD who are receiving intranasal esketamine or TMS.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Clinician determines Rejoyn is not suitable or safe for the patient
- Significant cognitive impairment that prevents app use
- Insufficient English proficiency to use Rejoyn
- Concurrent participation in another interventional study that would interfere with naturalistic data
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 |
|---|---|---|
| RejoynRejoyn is a 510(k)-cleared Prescription Digital Therapeutic (PDT) for adults with Major Depressive Disorder (MDD) as an adjunct to clinician-managed treatment. | Device | Rejoyn in participants with Major Depressive Disorder |
| Cognitive Behavioral Therapy (CBT) exercisesCognitive Behavioral Therapy (CBT) exercises, followed by an additional 6 weeks of access to the CBT content for additional review. | Behavioural | Rejoyn in participants with Major Depressive Disorder |
Primary outcome
Number of patients prescribed Rejoyn
Time frame: From screening through enrollment, approximately 1 week
Number of patients prescribed Rejoyn out of all eligible patients in the clinic
Mean participant app use to assess engagement
Time frame: up to Week 12
Mean number of times app was engaged
Mean duration of app use to assess engagement
Time frame: up to Week 12
Mean duration in minutes of app use
Mean number lessons completed to assess engagement
Time frame: up to Week 12
Mean number lessons completed
Number of participants adherent to Rejoyn
Time frame: up to Week 12
Adherence defined as completion of at least 12 of the 18 sessions
4 secondary outcomes
Change in Montgomery Asberg Depression Rating Scale (MADRS) score
Time frame: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
Change in Quick Inventory of Depressive Symptomatology (QIDS) score
Time frame: baseline, 2 weeks, 4 weeks, 6 weeks, and 12 weeks
Mean mHealth Satisfaction Questionnaire score
Time frame: baseline and 12-weeks
Number of clinicians that completed the Clinician Feasibility & Workflow Questionnaire
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder (MDD)
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
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.
Morgan Hardy, MD, MPH principal investigator
Yale University
Songjun W Li, MD PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD), run by Yale University at 2 sites 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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgan Hardy, MD, MPH ((203)764-9131, rewire.study@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients prescribed Rejoyn (time frame: From screening through enrollment, approximately 1 week). The study lists 5 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 9 Sep 2026.