Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

New Deplin® Start
Only for patients with depression who have been prescribed brand name Deplin® to help metabolic management of depression.
Clinically depressed patients who have been prescribed Deplin® in combination with an antidepressant.
At the start of antidepressant therapy
As augmentation to antidepressant therapy

Exclusion Criteria

Patients who do not meet DSM IV criteria for major depression
If participant indicates that he or she did not get a prescription for Deplin®, he/she will not be able to complete the survey(s).
For follow-up surveys, if the participant indicates that he/she has not been taking Deplin®, he/she will not be able to complete the survey(s).

Arm && Interventions

Group	Intervention	Description
Deplin®	Deplin®	Subjects with depression who have been prescribed Deplin® daily.

Primary Outcome Measures

Name	Time	Method
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)	Baseline to Endpoint (90 days)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale	Baseline to Endpoint (90 days)	Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating "not at all satisfied" and 9 as "very satisfied."
Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms	Baseline to Endpoint (90 days)

Locations (2): Moses Cone Family Practice Center
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Greensboro, North Carolina, United States
Vanderbilt University School of Medicine
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Nashville, Tennessee, United States