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Clinical Trials/NCT01430767
NCT01430767
Completed
Not Applicable

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

Wake Forest University Health Sciences1 site in 1 country33 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Wake Forest University Health Sciences
Enrollment
33
Locations
1
Primary Endpoint
Adherence to Standard-of-Care Medication for Depression or ADHD
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
December 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Adherence to Standard-of-Care Medication for Depression or ADHD

Time Frame: 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.

Study Sites (1)

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