Antidepressant Adherence for Depressed Adults in Primary Care

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Arm 1 intervention; Behavioral: Arm 2 Intervention

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 Type: Interventional
• Enrollment (Estimated): 525
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven C Marcus, PhD; Phone Number: 215-573-7941; Email: marcuss@upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Health System
      • Contact: Cadence F Bowden, MSW, MPH; Phone Number: 215-898-9995; Email: cbowden@upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Behavioral: Arm 1 intervention; This description is blinded.
Experimental: Arm 2	Behavioral: Arm 1 intervention; This description is blinded.; Behavioral: Arm 2 Intervention; This description is blinded
No Intervention: Arm 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptom response 12 weeks	A reduction of 50% in depression score from baseline as assessed by PHQ-9	12 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antidepressant adherence	measurement of antidepressant adherence through electronic pill bottles	6 and 12 weeks
Depression symptom response 6 weeks	A reduction of 50% in depression score from baseline as assessed by PHQ-9	6 weeks from baseline

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Medication adherence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Depression; Medication Adherence
• Other Study ID Numbers: 1R01MH135011-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No