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Recruiting NCT06496646

Antidepressant Adherence for Depressed Adults in Primary Care

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arm 1 intervention, Arm 2 Intervention.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 21 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Antidepressant Medication Adherence in Adults With Depression

Overview

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.

Interventions

  • Behavioral Arm 1 intervention
    This description is blinded.
  • Behavioral Arm 2 Intervention
    This description is blinded

Primary outcome measures

  • Depression symptom response 12 weeks [Time frame: 12 weeks from baseline]
Secondary outcome measures (2)
  • Antidepressant adherence [Time frame: 6 and 12 weeks]
  • Depression symptom response 6 weeks [Time frame: 6 weeks from baseline]

Eligibility criteria

Inclusion criteria

  • 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
  • Own a cell phone
  • Capable of using the electronic pill bottle
  • English-speaking

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Pennsylvania Health System — Philadelphia

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. PMID 42342396

Identifiers

NCT: NCT06496646 · 1R01MH135011-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗