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Completed

NCT Number: NCT01001559

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Red Oak Psychiatry Associates, PA

Houston, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-methylfolate

Drug

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

Other names: Deplin

Selective serotonin reuptake inhibitor (SSRI)

Drug

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.

Serotonin and norepinephrine reuptake inhibitor (SNRI)

Drug

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.

Primary outcomes

  1. Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline

    Time frame: 60 days

    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.

Secondary outcomes

  1. Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale

    Time frame: 60 days

    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.

  2. Number of Hospitalizations Due to MDD

    Time frame: 60 days

    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

  3. Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Pamlab, Inc.

Industry

Collaborators

  • Baylor Health Care System
  • Red Oak Psychiatry Associates, PA

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Oct 26, 2009
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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