Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
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)|
- Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline to Endpoint (90 days) ] [ Designated as safety issue: No ]The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value "0" represents not at all, "1" several days, "2" indicates more than half the days, and the maximum value "3" stands for nearly every day. The total possible range is 0-27. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
- Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms [ Time Frame: Baseline to Endpoint (90 days) ] [ Designated as safety issue: No ]
- Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale [ Time Frame: Baseline to Endpoint (90 days) ] [ Designated as safety issue: No ]Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating "not at all satisfied" and 9 as "very satisfied."
|Study Start Date:||November 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 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 a follow-up survey after 90 days of treatment with Deplin®. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369030
|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|