Antidepressant Adherence for Depressed Adults in Primary Care

University of Pennsylvania525 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Enrollment

525

Conditions

Depression

Interventions

Arm 1 interventionBEHAVIORAL

This description is blinded.

Arm 2 InterventionBEHAVIORAL

This description is blinded

Eligibility

Sex: ALLMin age: 21 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Depression symptom response 12 weeks

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

Time frame: 12 weeks from baseline

Secondary Outcomes

Antidepressant adherence

measurement of antidepressant adherence through electronic pill bottles

Time frame: 6 and 12 weeks

Depression symptom response 6 weeks

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

Time frame: 6 weeks from baseline

Central Contacts

Steven C Marcus, PhD

CONTACT

215-573-7941 marcuss@upenn.edu

Data from ClinicalTrials.gov

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