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| Name | Class |
|---|---|
| Red Oak Psychiatry Associates, PA | UNKNOWN |
| Baylor Health Care System | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deplin + antidepressant | Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) |
| |
| Antidepressant alone | SSRI or SNRI alone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults ages 18-70 experiencing an episode of major depression
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence D Ginsberg, MD | Red Oak Psychiatry Associates, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red Oak Psychiatry Associates, PA | Houston | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21311704 | Result | Ginsberg LD, Oubre AY, Daoud YA. L-methylfolate Plus SSRI or SNRI from Treatment Initiation Compared to SSRI or SNRI Monotherapy in a Major Depressive Episode. Innov Clin Neurosci. 2011 Jan;8(1):19-28. |
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Criteria that excluded patients were folic acid supplementation >400mcg, current or a history of psychotic features, bipolar disorder, a history of vagus nerve stimulation, electroconvulsive, or transcranial magnetic stimulation therapy. Any concomitant antipsychotic therapy in the most recent 4 weeks.
Single site, retrospective chart review of subjects administered a combination of Deplin and an SSRI or SNRI. The 242 subjects were 18-70 years of age (inclusive) and received their respective therapies between January 2007 and September 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Deplin + Antidepressant | Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) |
| FG001 | Antidepressant Alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
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| 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. |
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| 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 |
SSRI or SNRI alone
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Deplin + Antidepressant | Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) |
| BG001 | Antidepressant Alone | SSRI or SNRI alone |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants | Posted | Number | Participants | 60 days |
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| Secondary | 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. | All participants | Posted | Median | Inter-Quartile Range | Days | 60 days |
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| Secondary | 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 | Posted | Number | Hospitalizations due to MDD | 60 days |
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| Secondary | Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications | Posted | Number | Alterations in antidepressant therapy | 60 days |
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AE reporting occurred between January 2007 and September 2009
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deplin + Antidepressant | Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) | 1 | 93 | 56 | 93 | ||
| EG001 | Antidepressant Alone | SSRI or SNRI alone | 3 | 103 | 68 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment | Limited information regarding SAEs is available. Four hospitalizations, among three subjects in the Antidepressant Alone arm, and one hospitalization in the Deplin + Antidepressant arm occurred. No information regarding AE term or SOC is available. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sexual Dysfunction | Reproductive system and breast disorders |
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| Somnolence | Nervous system disorders |
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| Nausea | Gastrointestinal disorders |
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| Dizziness | Nervous system disorders |
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| Insomnia | Psychiatric disorders |
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| Agitation | Psychiatric disorders |
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| Decreased Appetite | Psychiatric disorders |
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| Constipation | Gastrointestinal disorders |
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| Fatigue | General disorders |
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| Dry Mouth | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lawrence Ginsberg | Red Oak Psychiatry Associates | 281-893-4111 | 151 | larrydg@earthlink.net |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C005984 | 5-methyltetrahydrofolate |
| D017367 | Selective Serotonin Reuptake Inhibitors |
| D000068760 | Serotonin and Noradrenaline Reuptake Inhibitors |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |
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| Male |
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