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

NCT01369030 | Completed Results

• 1 other identifier: D-009
• Study Type: observational
• Target: 554
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder

Keywords

L-methylfolate; Deplin; depression; antidepressant; combination therapy; augmentation; folate; folic acid; homocysteine; methionine; MTHFR genotype; C677T mutation; vitamin B6; vitamin B12

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  Baseline to Endpoint (90 days)

Study Arms (1)

Deplin®

Subjects with depression who have been prescribed Deplin® daily.

Other: Deplin®

Interventions

Deplin® OTHER

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.

Deplin®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Depression Who Have Been Prescribed Deplin®

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pamlab, Inc.: lead
• InfoMedics, Inc.: collaborator

Study Sites (2)

Moses Cone Family Practice Center

Greensboro, North Carolina, 27401, United States

Location

Vanderbilt University School of Medicine

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

5-methyltetrahydrofolate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Patients self-enrolled in the program and data presented was based on self-reported close-ended questions; selection bias may be present for those who chose not to enroll or complete the surveys. No clinical evaluations were conducted.

Results Point of Contact

• Title: Lori W Barrentine, MS, PA-C, Director of Clinical Affairs
• Organization: Pamlab, Inc.

lbarrentine@pamlab.com

985-867-5788

Study Officials

• Richard C Shelton, M.D.

  Vanderbilt University School of Medicine

  PRINCIPAL INVESTIGATOR

• Sloan Manning, M.D.

  Mood Disorders Clinic at Moses Cone Family Practice Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: June 8, 2011
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 3, 2014
• Results First Posted: June 3, 2014

Record last verified: 2014-05

Locations

US (2)