Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression (HAM-D)
研究概览
简要总结
The investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II postpartum depression. Women who are taking a mood stabilizer for treatment of bipolar disorder in the postpartum treatment will receive either a placebo or celecoxib add-on treatment. Patients will be monitored regularly to assess psychiatric symptoms and side effects. The investigators aim to evaluate the potential antidepressant effect of celecoxib in bipolar postpartum depression.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-45 who are within 3 months of delivering a healthy, term (37 to 40 weeks) singleton
- •diagnosis of bipolar postpartum depression - depressed with peripartum onset
- •have a 17-item Hamilton Rating Scale for Depression score of >18
- •have failed to respond to an adequate trial of the mood stabilizer
- •are currently not on any psychotropic drug except a mood stabilizer (lithium, lamotrigine or quetiapine)
- •are able to communicate (written and oral) in English and capable of giving consent
排除标准
- •current major depressive episode of more than 6 months duration
- •a current comorbid psychiatric disorder
- •history of alcohol or substance abuse within the 12 months before screening
- •concurrent psychotherapy
- •high risk for suicide (actively suicidal or a score of = 3 on item #3 on HAM-D)
- •current hepatic, renal, or cardiac disease, chronic pain, coagulation disorders, esophageal or gastro duodenal ulceration within the previous 30 days
- •known immediate-type hypersensitivity to COX-2 inhibitors, sulfonamides, ibuprofen, or diclofenac
- •breastfeeding mothers
研究组 & 干预措施
Celecoxib
Adjunct celecoxib in 6 week treatment
干预措施: Celecoxib (Drug)
Placebo
Adjunct placebo in 6 week treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression (HAM-D)
时间窗: 6 weeks
To assess the effectiveness of the addition of celecoxib in the treatment of bipolar postpartum depression by the change in mean scores on the HAM-D between baseline and the 6 weeks endpoint. Response will be a \> 50% reduction in HAM-D score and remission will be a \< 7 HAM-D score from baseline to week 6.
次要结局
- Edinburgh Postnatal Depression Scale (EPDS)(6 weeks)
- Montgomery Asberg Depression Scale(6 weeks)
- Udvalg for Kliniske Undersogelser Scale(6 weeks)
- Clinical Global Impression Scale (CGI)(6 weeks)