Major Depressive Disorder Clinical Trial
Official title:
Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
Verified date | May 2014 |
Source | Pamlab, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 554 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Moses Cone Family Practice Center | Greensboro | North Carolina |
United States | Vanderbilt University School of Medicine | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Pamlab, Inc. | InfoMedics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | 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. | Baseline to Endpoint (90 days) | No |
Secondary | Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms | Baseline to Endpoint (90 days) | No | |
Secondary | Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale | Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating "not at all satisfied" and 9 as "very satisfied." | Baseline to Endpoint (90 days) | No |
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