N/A
N=242
Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01001559 ↗Enrolled (actual)
242
Serious AEs
2.0%
Results posted
Dec 2013
Primary outcome: Primary: Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline — 17; 10 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- L-methylfolate (Drug); Selective serotonin reuptake inhibitor (SSRI) (Drug); Serotonin and norepinephrine reuptake inhibitor (SNRI) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pamlab, Inc.
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline |
17; 10 | — |
| SECONDARY Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale |
177; 231 | — |
| SECONDARY Number of Hospitalizations Due to MDD |
1; 4 | — |
| SECONDARY Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications |
135; 263 | — |
Summary
This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.
Eligibility Criteria
Inclusion Criteria
- Males or females age 18-70
- The active arm (Arm #1) includes randomly selected 100-125 charts of patients with a primary diagnosis of major depression and a CGI-S of ≥4 who began Deplin and SSRI or SNRI therapy at the same time beginning in January 2007 to the present; and, Control group (Arm #2) includes randomly selected 125-150 charts of patients with a primary diagnosis of major depression who began SSRI or SNRI therapy matched in severity (CGI-S of ≥4)
Exclusion Criteria
- Folic acid >400 mcg taken at any time during the study
- Psychotic features in the current episode or a history of psychotic features
- Any bipolar disorder (current or past) or any psychotic disorder (current or past)
- Current or past treatment with vagus nerve stimulation, ECT, or transcranial magnetic stimulation
- Antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks
Data sourced from ClinicalTrials.gov (NCT01001559). 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.