Recruiting

Antidepressant Adherence

Sponsor:

University of Pennsylvania

Code:

NCT06496646

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Not accepted

Interventions

Arm 1 intervention

Arm 2 Intervention

Study Details

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

Study ID

NCT06496646

Start date

Mar 19, 2025

Status verified date

Nov, 2025

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

525 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Arm 1

experimental: Arm 2

no intervention: Arm 3

Interventions

Arm 1 intervention

This description is blinded.

Arm 2 Intervention

This description is blinded

Primary outcome measure

  • Depression symptom response 12 weeks [ Time Frame: 12 weeks from baseline ]

Central Contacts and Locations

Central contacts

Steven C Marcus, PhD

215-573-7941marcuss@upenn.edu

Locations

University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Cadence F Bowden, MSW, MPH

215-898-9995cbowden@upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • Medication adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-11-26.