Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
Recruitment status was Active, not recruiting
This study will be an observational study in which patients who have been prescribed Deplin® are invited to participate in surveys regarding their experiences with Deplin®. The purpose of this study is to increase the understanding of the role of L-methylfolate among patients who are candidates for Deplin®, provide patients with personalized education and support, and contribute to the overall understanding of the needs and concerns of patients being treated for depression.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)|
- To determine if Deplin® affects a subject's severity of depression by assessing symptoms and functional impairment using the PHQ-9 Depression Scale [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire.
- To determine if Deplin® affects the impact of depression on a subject's functionality [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
- To predict medication adherence to Deplin® [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
- To determine overall patient satisfaction with Deplin® using a 9-point satisfaction scale [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Subjects with depression who have been prescribed Deplin® daily.
Deplin® is an orally administered medical food available in a 7.5mg tablet or a 15mg caplet with each containing either 7.5mg or 15mg of L-methylfolate, respectively - which is the primary biologically active and immediately bioavailable form of folate. Dosage for this study will be 1 15mg caplet QD.
Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Deplin® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their Deplin® prescription, and then two brief follow-up surveys at 6 weeks and 12 weeks. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Deplin® as directed. Patients will also receive educational materials about managing their depression.
|United States, North Carolina|
|Moses Cone Family Practice Center|
|Greensboro, North Carolina, United States, 27401|
|United States, Tennessee|
|Vanderbilt University School of Medicine|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Richard C Shelton, M.D.||Vanderbilt University School of Medicine|
|Principal Investigator:||Sloan Manning, M.D.||Mood Disorders Clinic at Moses Cone Family Practice Center|