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

This study has been completed.
Information provided by (Responsible Party):
Guy K. Palmes, M.D., Wake Forest Baptist Health Identifier:
First received: September 6, 2011
Last updated: December 17, 2015
Last verified: December 2015
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.

Major Depressive Disorder
Attention-deficit Hyperactivity Disorder (ADHD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Adherence to Standard-of-Care Medication for Depression and ADHD in a College Student Population

Resource links provided by NLM:

Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Adherence to Standard-of-Care Medication for Depression or ADHD [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 20
Study Start Date: September 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Twenty male and female subjects, ten with depression and ten with ADHD, will be recruited. Subjects will be recruited from the Student Health Clinic at Wake Forest University, as we plan to assess adherence in a typical population of college students with depression or ADHD.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01430767

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
Principal Investigator: Guy K Palmes, MD Wake Forest School of Medicine
  More Information

Responsible Party: Guy K. Palmes, M.D., Associate Professor of Psychiatry & Behavioral Medicine, Wake Forest Baptist Health Identifier: NCT01430767     History of Changes
Other Study ID Numbers: WFBMC-Psych-17564 
Study First Received: September 6, 2011
Last Updated: December 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Depressive Disorder
Depressive Disorder, Major
Attention Deficit and Disruptive Behavior Disorders
Behavioral Symptoms
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurodevelopmental Disorders
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms processed this record on May 25, 2016