N/A
Completed N=594
Deplin® P.L.U.S. Program (Progress Through Learning Understanding & Support)
Source: ClinicalTrials.gov NCT01369030 ↗Enrolled (actual)
594
Serious AEs
—
Results posted
Jun 2014
Primary outcomePrimary: Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) — 14.6; 6.1; 8.5 units on a scale — p=0.000
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) |
14.6; 6.1; 8.5 | 0.000 sig |
| SECONDARY Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms |
37.5 | — |
| SECONDARY Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale |
7.0 | — |
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).
Data sourced from ClinicalTrials.gov (NCT01369030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.