Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
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|ClinicalTrials.gov Identifier: NCT01369030|
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder||Other: Deplin®|
|Study Type :||Observational|
|Actual Enrollment :||554 participants|
|Official Title:||Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Subjects with depression who have been prescribed Deplin® daily.
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.
- Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline to Endpoint (90 days) ]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.
- Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms [ Time Frame: Baseline to Endpoint (90 days) ]
- Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale [ Time Frame: Baseline to Endpoint (90 days) ]Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating "not at all satisfied" and 9 as "very satisfied."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369030
|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|
|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|