Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pamlab, Inc.
- 入组人数
- 554
- 试验地点
- 2
- 主要终点
- Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
时间窗: 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.
次要结局
- Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale(Baseline to Endpoint (90 days))
- Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms(Baseline to Endpoint (90 days))