Combination Deplin® and Antidepressant Therapy Compared to Antidepressant Therapy Alone for an Episode of Major Depression- a Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pamlab, Inc.
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Deplin + antidepressant
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
干预措施: Selective serotonin reuptake inhibitor (SSRI) (Drug)
Deplin + antidepressant
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
干预措施: L-methylfolate (Drug)
Deplin + antidepressant
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
干预措施: Serotonin and norepinephrine reuptake inhibitor (SNRI) (Drug)
Antidepressant alone
SSRI or SNRI alone
干预措施: Selective serotonin reuptake inhibitor (SSRI) (Drug)
Antidepressant alone
SSRI or SNRI alone
干预措施: Serotonin and norepinephrine reuptake inhibitor (SNRI) (Drug)
结局指标
主要结局
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline
时间窗: 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.
次要结局
- Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale(60 days)
- Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications(60 days)
- Number of Hospitalizations Due to MDD(60 days)