Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis

Study Overview
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Brief Summary
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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.

Official Title
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Combination Deplin® and Antidepressant Therapy Compared to Antidepressant Therapy Alone for an Episode of Major Depression- a Retrospective Analysis

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: L-methylfolate
* Drug: Selective serotonin reuptake inhibitor (SSRI)
* Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Deplin + antidepressant<br>Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) | Drug: L-methylfolate<br>* Subjects must have been on their respective therapies for a minimum of 60 days. L-methylfolate dosing was 7.5 mg or 15 mg daily<br>* Other names: Deplin;Drug: Selective serotonin reuptake inhibitor (SSRI)<br>* Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.<br>Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)<br>* Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.<br>|
| Antidepressant alone<br>SSRI or SNRI alone | Drug: Selective serotonin reuptake inhibitor (SSRI)<br>* Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.<br>Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)<br>* Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline | The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. Number of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline. | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale | The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. Median times to peak response. Peak response defined as the first improvement of two or more in the CGI-S from initial visit, and measured the time to the occurrence. | 60 days | 
| Number of Hospitalizations Due to MDD | Number of hospitalizations due to MDD during treatment were assessed during this retrospective analysis of L-methylfolate plus SSRI/SNRI at treatment initiation (n=95) and SSRI/SNRI monotherapy (n-147) from patient charts | 60 days | 
| Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Combination therapy, antidepressant, Deplin, folate, methylfolate