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

This study has been completed.
Sponsor:
Collaborator:
InfoMedics, Inc.
Information provided by (Responsible Party):
Pamlab, Inc.
ClinicalTrials.gov Identifier:
NCT01369030
First received: May 17, 2011
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Other: Deplin®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)

Resource links provided by NLM:


Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline to Endpoint (90 days) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms [ Time Frame: Baseline to Endpoint (90 days) ] [ Designated as safety issue: No ]
  • Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale [ Time Frame: Baseline to Endpoint (90 days) ] [ Designated as safety issue: No ]
    Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating "not at all satisfied" and 9 as "very satisfied."


Enrollment: 554
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Deplin®
Subjects with depression who have been prescribed Deplin® daily.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with Depression Who Have Been Prescribed Deplin®

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369030

Locations
United States, North Carolina
Moses Cone Family Practice Center
Greensboro, North Carolina, United States, 27401
United States, Tennessee
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Pamlab, Inc.
InfoMedics, Inc.
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT01369030     History of Changes
Other Study ID Numbers: D-009
Study First Received: May 17, 2011
Results First Received: April 18, 2013
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pamlab, Inc.:
L-methylfolate
Deplin
depression
antidepressant
combination therapy
augmentation
folate
folic acid
homocysteine
methionine
MTHFR genotype
C677T mutation
vitamin B6
vitamin B12

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014