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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
InfoMedics, Inc.
Information provided by (Responsible Party):
Pamlab, Inc. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier:
NCT01369030
First received: May 17, 2011
Last updated: January 9, 2012
Last verified: June 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • To determine if Deplin® affects a subject's severity of depression by assessing symptoms and functional impairment using the PHQ-9 Depression Scale [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire.


Secondary Outcome Measures:
  • To determine if Deplin® affects the impact of depression on a subject's functionality [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • To predict medication adherence to Deplin® [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • To determine overall patient satisfaction with Deplin® using a 9-point satisfaction scale [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 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 two brief follow-up surveys at 6 weeks and 12 weeks. 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
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, L.L.C.
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. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier: NCT01369030     History of Changes
Other Study ID Numbers: D-009
Study First Received: May 17, 2011
Last Updated: January 9, 2012
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 May 16, 2013