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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Guy K. Palmes, M.D., Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT01430767
First received: September 6, 2011
Last updated: August 21, 2014
Last verified: August 2014

September 6, 2011
August 21, 2014
September 2011
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01430767 on ClinicalTrials.gov Archive Site
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Measuring Adherence to Medication for Depression and Attention-deficit Hyperactivity Disorder
Measuring Adherence to Standard-of-Care Medication for Depression and ADHD in a College Student Population

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

  • Major Depressive Disorder
  • Attention-deficit Hyperactivity Disorder (ADHD)
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01430767
WFBMC-Psych-17564
No
Guy K. Palmes, M.D., Wake Forest Baptist Health
Wake Forest Baptist Health
Not Provided
Principal Investigator: Guy K Palmes, MD Wake Forest School of Medicine
Wake Forest Baptist Health
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP