Antidepressant Adherence for Depressed Adults in Primary Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

525 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-19

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Arm 1 intervention

Intervention Type BEHAVIORAL

This description is blinded.

Arm 2

Group Type EXPERIMENTAL

Arm 1 intervention

Intervention Type BEHAVIORAL

This description is blinded.

Arm 2 Intervention

Intervention Type BEHAVIORAL

This description is blinded

Arm 3

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Arm 1 intervention

This description is blinded.

Intervention Type BEHAVIORAL

Arm 2 Intervention

This description is blinded

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No