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

Pamlab

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Other: Deplin®

Study type: Observational

Funder types: Industry

Identifiers

NCT01369030

D-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 554 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

554 participants in 1 patient group

Deplin®

Description:

Subjects with depression who have been prescribed Deplin® daily.

Treatment:

Other: Deplin®