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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Wake Forest Baptist Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Guy K. Palmes, M.D., Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01430767
First received: September 6, 2011
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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
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
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430767

Contacts
Contact: Guy K Palmes, MD 3367162011 gpalmes@wakehealth.edu
Contact: Sebastian G Kaplan, PhD 3367164551 sgkaplan@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Guy K Palmes, MD    336-716-2011    gpalmes@wakehealth.edu   
Contact: Sebastian G Kaplan, PhD    3367164551    sgkaplan@wakehealth.edu   
Principal Investigator: Guy K Palmes, MD         
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: Guy K Palmes, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Guy K. Palmes, M.D., Associate Professor of Psychiatry & Behavioral Medicine, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01430767     History of Changes
Other Study ID Numbers: WFBMC-Psych-17564
Study First Received: September 6, 2011
Last Updated: September 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Attention Deficit Disorder with Hyperactivity
Depressive Disorder, Major
Hyperkinesis
Behavioral Symptoms
Mood Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014