Clinical trial NCT01369030: Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
Official title: Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Pamlab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: InfoMedics, Inc.
First posted: 2011-06-08
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Depression Who Have Been Prescribed Deplin®

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.

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 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).

Primary outcomes:
measure: Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline to Endpoint (90 days)
Secondary outcomes:
measure: Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms
timeFrame: Baseline to Endpoint (90 days)
measure: Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale
timeFrame: Baseline to Endpoint (90 days)
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: Moses Cone Family Practice Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Richard C Shelton, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mood Disorders Clinic at Moses Cone Family Practice Center
name: Sloan Manning, M.D.
role: PRINCIPAL_INVESTIGATOR
References: