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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Other: Deplin®


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Deplin®<br>Subjects with depression who have been prescribed Deplin® daily. | Other: Deplin®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | 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. | Baseline to Endpoint (90 days) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deplin, L-methylfolate, depression, antidepressant, combination therapy, augmentation, folate, folic acid, homocysteine, methionine, MTHFR genotype, C677T mutation, vitamin B6, vitamin B12