DepressionNCT06496646
Antidepressant Adherence for Depressed Adults in Primary Care
A study testing Arm 1 intervention and Arm 2 Intervention in people with Depression, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this study is to test ways to help people improve their health and manage their medication for depression. This study will measure both medication adherence and depression outcomes. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Depression
- What is being tested?
- Arm 1 intervention and Arm 2 Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to 31 Mar 2029
- Phase
- Interventional
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Penn Medicine primary care outpatients
- Clinical diagnosis of major depressive disorder
- A score of 10+ on the Patient Health Questionnaire 9 (PHQ-9)
- Age 21 to 64 years at the time of study entry
- Prescribed an antidepressant by their primary care clinician
- Express interest in taking antidepressant medication
Show all 9Show fewer
- Own a cell phone
- Capable of using the electronic pill bottle
- English-speaking
Who cannot join
- Treated with antidepressants in the past 90 days
- Pregnant or breastfeeding
- An active substance use disorder other than nicotine
- A lifetime history of treatment for bipolar disorder or schizophrenia
- Hospital admission or emergency department visit for suicidal symptoms in the past year
- Lack capacity to provide informed consent
- Using antidepressant more than 10 days at baseline assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Cadence F Bowden, MSW, MPH, 215-898-9995, cbowden@upenn.edu
About this study
Official title: Antidepressant Medication Adherence in Adults With Depression
The goal of this study is to test ways to help people improve their health and manage their medication for depression. This study will measure both medication adherence and depression outcomes.
Read the detailed description
Participants in the study will be given a special pill bottle for depression medication. This pill bottle will track how often the bottle is opened to take medication and it will transmit that information to the research team. Participation will last 12 weeks, and will include an initial assessments over the phone and follow-up assessments over the phone or electronically approximately 6 weeks and 12 weeks later. During these assessments, a research coordinator will ask questions about your mood, quality of life, participation in the management of depression, and related topics.
- Conditions
- Depression
- Being tested
- Arm 1 intervention, Arm 2 Intervention
- Keywords
- Medication adherence
- Medical subject headings
- Depression, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 interventionBehavioural
This description is blinded.
Arm 2 InterventionBehavioural
This description is blinded
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Behavioral: Arm 1 intervention |
| Arm 2 | Experimental | Not described Receives: Behavioral: Arm 1 intervention; Behavioral: Arm 2 Intervention |
| Arm 3 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptom response 12 weeks
A reduction of 50% in depression score from baseline as assessed by PHQ-9
Measured: 12 weeks from baseline
Secondary outcomes (2)
Antidepressant adherence
measurement of antidepressant adherence through electronic pill bottles
Measured: 6 and 12 weeks
Depression symptom response 6 weeks
A reduction of 50% in depression score from baseline as assessed by PHQ-9
Measured: 6 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start19 Mar 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496646
- Sponsor's protocol ID
- 1R01MH135011-01A1
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study, de-identified data from this study, including individual-level data and associated documentation, will be submitted to the NIMH Data Archive in compliance with NIMH policies. The data will be made available to qualified researchers upon request.
Publications
Marcus SC, Bowden CF, Lynch KG, Olfson M. Three-arm randomised controlled trial of text message reminders and financial incentives to improve antidepressant adherence among adults in primary care with depression: study protocol. BMJ Open. 2026 Jun 24;16(6):e121721. doi: 10.1136/bmjopen-2026-121721.
PubMed 42342396
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant Medication Adherence in Adults With Depression
- ClinicalTrials.gov ID
- NCT06496646
- Acronym / sponsor ID
- 1R01MH135011-01A1
- Conditions
- Depression
- Keywords
- Medication adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 11 Jul 2024 (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.
The goal of this study is to test ways to help people improve their health and manage their medication for depression. This study will measure both medication adherence and depression outcomes.
Detailed description
Participants in the study will be given a special pill bottle for depression medication. This pill bottle will track how often the bottle is opened to take medication and it will transmit that information to the research team. Participation will last 12 weeks, and will include an initial assessments over the phone and follow-up assessments over the phone or electronically approximately 6 weeks and 12 weeks later. During these assessments, a research coordinator will ask questions about your mood, quality of life, participation in the management of depression, and related topics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Arm 1 intervention |
| Arm 2 | Experimental | Behavioral: Arm 1 intervention, Behavioral: Arm 2 Intervention |
| Arm 3 | No intervention | – |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Penn Medicine primary care outpatients
- Clinical diagnosis of major depressive disorder
- A score of 10+ on the Patient Health Questionnaire 9 (PHQ-9)
- Age 21 to 64 years at the time of study entry
- Prescribed an antidepressant by their primary care clinician
Key exclusion criteria (7 listed)
- Treated with antidepressants in the past 90 days
- Pregnant or breastfeeding
- An active substance use disorder other than nicotine
- A lifetime history of treatment for bipolar disorder or schizophrenia
- Hospital admission or emergency department visit for suicidal symptoms in the past year
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 |
|---|---|---|
| Arm 1 interventionThis description is blinded. | Behavioural | Arm 1, Arm 2 |
| Arm 2 InterventionThis description is blinded | Behavioural | Arm 2 |
Primary outcome
Depression symptom response 12 weeks
Time frame: 12 weeks from baseline
A reduction of 50% in depression score from baseline as assessed by PHQ-9
2 secondary outcomes
Antidepressant adherence
Time frame: 6 and 12 weeks
Depression symptom response 6 weeks
Time frame: 6 weeks from baseline
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 26 Nov 2025.
- Derived from this study: PubMed 42342396Marcus SC, Bowden CF, Lynch KG, Olfson M. Three-arm randomised controlled trial of text message reminders and financial incentives to improve antidepressant adherence among adults in primary care with depression: study protocol. BMJ Open. 2026 Jun 24;16(6):e121721. doi: 10.1136/bmjopen-2026-121721.
- Individual participant dataSharing planned: Yes. After completion of the study, de-identified data from this study, including individual-level data and associated documentation, will be submitted to the NIMH Data Archive in compliance with NIMH policies. The data will be made available to qualified researchers upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 intervention and Arm 2 Intervention in people with Depression, run by University of Pennsylvania 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. 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?
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 Steven C Marcus, PhD (215-573-7941, marcuss@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptom response 12 weeks (time frame: 12 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496646, which also lists 1 linked publication.
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 26 Nov 2025.