NCT00566111终止不适用
Modulation of Glutamatergic Neurotransmission in the Treatment of Bipolar Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.
研究概览
简要总结
We aim to study the efficacy of intravenous ceftriaxone in a four-week, inpatient, placebo-controlled, double-blind study, as an augmentation therapy in patients with bipolar disorder, currently depressed, who have failed to respond to conventional treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of bipolar disorder
- •Presence of a current major depressive episode on the SCID
- •Score of 17 or greater on the HDRS
- •Failure to respond to two previous medication trials
- •Capable of giving voluntary written consent
排除标准
- •Hypersensitivity to penicillin or cephalosporin, resulting in anaphylaxis
- •Significant current substance dependence/abuse within 3 months preceding the trial
- •Significant history of intravenous drug abuse
- •Active suicidal ideation
- •Pregnant/lactating mothers
- •Significant medical history
- •Patients on anticoagulation treatment
- •Patients who test positive for HIV or Hep B or C
研究组 & 干预措施
A
Active Comparator
干预措施: ceftriaxone (Drug)
P
Placebo Comparator
干预措施: Saline solution (Drug)
结局指标
主要结局
Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.
时间窗: 4 weeks
Number of patients with scores that decreased at four weeks.
次要结局
- Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.(4 weeks)
- Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.(4 weeks)
- Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).(4 weeks)
- Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.(4 weeks)
研究者
研究点 (1)
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