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

NCT01369030 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 554

Last updated 2014-06-03

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • InfoMedics, Inc.

    collaborator INDUSTRY

  • Pamlab, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard C Shelton, M.D. · Vanderbilt University School of Medicine

  • Sloan Manning, M.D. · Mood Disorders Clinic at Moses Cone Family Practice Center

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369030 on ClinicalTrials.gov