Measuring Adherence to Medication for Depression and Attention-deficit Hyperactivity Disorder

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01430767

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Poor adherence is a common reason for treatment failure in many fields of medicine, and likely affects common psychiatric treatments as well. Members of the present study team have used Medication Event Monitoring System (MEMS®) caps effectively to objectively monitor adherence in skin disease, and have shown that they provide a much more accurate measure of adherence behavior than self-reports, pill counts, or serum drug concentrations. The present study will use MEMS® caps to measure adherence in 10 patients with depression and 10 patients with attention-deficit hyperactivity disorder (ADHD) from a student clinic population. The aims will be to show the usefulness of MEMS® caps in measuring adherence to psychiatric treatment, and gather data on typical adherence rates for depression and ADHD patients on typical treatment regimens. The data obtained will be used to inform future studies that use an intervention to improve adherence behavior and ultimately disease outcomes.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Attention-deficit Hyperactivity Disorder (ADHD)

Study Design

Study Type:

Observational

Actual Enrollment :

33 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Measuring Adherence to Standard-of-Care Medication for Depression and ADHD in a College Student Population

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Depression Ten subjects with diagnosis of major depressive disorder from the Wake Forest University Student Health Clinic, being treated with FDA-approved standard-of-care medication for depression.
ADHD Ten subjects with a diagnosis of attention-deficit hyperactivity disorder (ADHD) from the Wake Forest University Student Health Clinic, being treated with FDA-approved standard-of-care medication for their ADHD.

Outcome Measures

Primary Outcome Measures

Adherence to Standard-of-Care Medication for Depression or ADHD [4 weeks]
Adherence to standard-of-care medication for depression or ADHD will be objectively measured using a bottle fitted with a Medication Event Monitoring System (MEMS®) cap and the percentage of prescribed doses taken will be reported as the outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any male or female, at least 18 years of age, using the Student Health Clinic, with a diagnosis of depression or ADHD.
Written consent of participation must be given by the subject.

Exclusion Criteria:

Subject is less than 18 years of age.
Inability to complete all study-related visits.
Introduction of any other prescription medication while participating in the study. (Patients who are on a stable dose of non-study-related prescription medications for at least 4 weeks prior to the study, and throughout the study period, are not excluded.)
Female patients whose medications may be harmful during pregnancy must be on an acceptable form of birth control, otherwise they will not be eligible for participation.