Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| InfoMedics, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deplin® | Subjects with depression who have been prescribed Deplin® daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deplin® | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms | Baseline to Endpoint (90 days) | |
| 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." |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with Depression Who Have Been Prescribed Deplin®
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moses Cone Family Practice Center | Greensboro | North Carolina | 27401 | United States | ||
| Vanderbilt University School of Medicine |
Participants may have excluded themselves from the overall study after self-enrolling in the program if they did not complete the designated surveys prior to using Deplin® (Baseline) or at the 90-day time point post-treatment initiation.
Between November 2010 and January 2012, patients of at least 18 years of age who had been prescribed Deplin® by their physician for the treatment of major depression were offered to participate in the study by their prescibing physician, consisting of about 550 participating physicians located at various clinical sites country-wide.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Deplin® | Subjects with depression who have been prescribed Deplin® daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 594 completed the baseline and follow-up surveys and of those only 554 with a baseline PHQ-9>=5 were included in the analysis. Majority of the participants were female, and the study was approximately equal distribution across the four depression severity groups of interest.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Deplin® | Subjects with depression who have been prescribed Deplin® daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analyses were performed on the 554 patients who had a baseline PHQ-9>=5 and further analyzed by baseline depression severity groups defined by baseline PHQ-9 scores: 5<=PHQ-9<=9; 10<=PHQ-9<=14; 15<=PHQ-9<=19; and 20<=PHQ-9<=27. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Endpoint (90 days) |
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deplin® | Subjects with depression who have been prescribed Deplin® daily. |
Not provided
Not provided
Patients self-enrolled in the program and data presented was based on self-reported close-ended questions; selection bias may be present for those who chose not to enroll or complete the surveys. No clinical evaluations were conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori W Barrentine, MS, PA-C, Director of Clinical Affairs | Pamlab, Inc. | 985-867-5788 | lbarrentine@pamlab.com |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C005984 | 5-methyltetrahydrofolate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline to Endpoint (90 days) |
| Nashville |
| Tennessee |
| 37212 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Baseline gender characteristic categories include female, male, and unknown. 16 enrolled subjects were listed as unknown. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Deplin® | Subjects with depression who have been prescribed Deplin® daily. |
|
|
|
| Secondary | Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms | Posted | Number | percentage of participants | Baseline to Endpoint (90 days) |
|
|
|
| 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." | Posted | Mean | Full Range | units on a scale | Baseline to Endpoint (90 days) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| D001519 |
| Behavior |