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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369030
• Other study ID #: D-009
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: May 8, 2014
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: May 2014
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Deplin®
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.

Locations

Country	Name	City	State
United States	Moses Cone Family Practice Center	Greensboro	North Carolina
United States	Vanderbilt University School of Medicine	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Pamlab, Inc.	InfoMedics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms		Baseline to Endpoint (90 days)	No
Secondary	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)	No