Major Depressive Disorder
Conditions
Keywords
L-methylfolate, Deplin, depression, antidepressant, combination therapy, augmentation, folate, folic acid, homocysteine, methionine, MTHFR genotype, C677T mutation, vitamin B6, vitamin B12
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.
Interventions
OTHERDeplin®
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
InfoMedics, Inc.
Pamlab, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Deplin® Subjects with depression who have been prescribed Deplin® daily. | 554 |
| Total | 554 |
Baseline characteristics
| Characteristic | Deplin® |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 84 Participants |
| Age, Categorical Between 18 and 65 years | 470 Participants |
| Age, Continuous | 49.9 years STANDARD_DEVIATION 14.1 |
| Gender Female | 424 participants |
| Gender Male | 114 participants |
| Region of Enrollment United States | 554 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Baseline to Endpoint (90 days)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deplin® | Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | Mean baseline PHQ-9 Score | 14.6 units on a scale | Standard Deviation 5.8 |
| Deplin® | Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | Mean endpoint PHQ-9 Score | 6.1 units on a scale | Standard Deviation 5 |
| Deplin® | Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | Mean reduction in PHQ-9 Score | 8.5 units on a scale | Standard Deviation 6.3 |
p-value: 0Wilcoxon signed-rank test
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.
Time frame: Baseline to Endpoint (90 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Deplin® | Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale | 7.0 units on a scale |
Secondary
Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms
Time frame: Baseline to Endpoint (90 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deplin® | Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms | 37.5 percentage of participants |