Antidepressant Adherence for Depressed Adults in Primary Care

NCT06496646 | Recruiting DMC

• 1 other identifier: 1R01MH135011-01A1
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Medication adherence

Outcome Measures

Primary Outcomes (1)

• Depression symptom response 12 weeks

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

  12 weeks from baseline

Secondary Outcomes (2)

• Antidepressant adherence

  6 and 12 weeks

• Depression symptom response 6 weeks

  6 weeks from baseline

Study Arms (3)

Arm 1

EXPERIMENTAL

Behavioral: Arm 1 intervention

Arm 2

EXPERIMENTAL

Behavioral: Arm 1 intervention; Behavioral: Arm 2 Intervention

Arm 3

NO INTERVENTION

Interventions

Arm 1 intervention BEHAVIORAL

This description is blinded.

Arm 1; Arm 2

Arm 2 Intervention BEHAVIORAL

This description is blinded

Arm 2

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Depression; Medication Adherence

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Central Study Contacts

Steven C Marcus, PhD

CONTACT

215-573-7941; marcuss@upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: March 19, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)