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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430767
• Other study ID #: WFBMC-Psych-17564
• Status: Completed
• Phase: N/A
• First received: September 6, 2011
• Last updated: April 18, 2017
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit Hyperactivity Disorder (ADHD)
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Hyperkinesis
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Standard-of-Care Medication for Depression or ADHD	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.	4 weeks