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Recruiting

NCT Number: NCT06496646

Antidepressant Adherence for Depressed Adults in Primary Care

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.

Recruiting

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Key information

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Cadence F Bowden, MSW, MPH

CONTACT

[email protected]

215-898-9995

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 1 Intervention

Behavioral

This description is blinded.

Arm 2 Intervention

Behavioral

This description is blinded

Primary outcomes

  1. 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

Secondary outcomes

  1. Antidepressant adherence

    Time frame: 6 and 12 weeks

    measurement of antidepressant adherence through electronic pill bottles

  2. Depression symptom response 6 weeks

    Time frame: 6 weeks from baseline

    A reduction of 50% in depression score from baseline as assessed by PHQ-9

Study contacts

Contact information is provided by the study sponsor or research team.

Steven C Marcus, PhD

CONTACT

[email protected]

215-573-7941

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Antidepressant Medication Adherence in Adults With Depression

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 11, 2024
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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