NCT01413854撤回1 期
"Antiinflammatoriska läkemedels Effekt för Att Minska Suicidalitet Hos Deprimerade Patienter Som Nyligen Har Gjort självmordsförsök"
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Region Skane
- 试验地点
- 1
- 主要终点
- Suicide Assessment Scale (differences in scores before and after treatment)
研究概览
简要总结
The purpose of this study is to determine whether diclofenac is effective in the treatment of depressed patients with a recent suicide attempt.
详细描述
The study will start with a feasibility study including treatment of 10 patients with diclofenac.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Depressive disorder
- •Montgomery Asberg Rating Scale Score more than 20 p.
- •Recent suicide attempt (Treated as inpatient due to a recent suicide attempt)
- •Informed consent
- •Competence to give informed consent
排除标准
- •Pregnancy
- •Breastfeeding
- •Serious somatic disease e.g. serious heart, vascular, hepatic, kidney, pulmonary, intestinal, endocrine, haematological or neurological diseases
- •Ongoing substance abuse
- •Schizophrenia or other psychotic disorders
- •Ongoing psychosis
- •Risk factors for cardiovascular events
- •Ulcer or gastrointestinal bleeding
- •Ongoing Electroconvulsive therapy
- •Previous allergic reaction to NSAID, acetylsalicylic acid, sulfonamides or the diclofenac or sugar pill content
- •Galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- •Ongoing treatment with warfarin or other anticoagulants
- •Ongoing treatment with ACE inhibitors or angiotensin II antagonists Ongoing treatment with drugs known to effect the immune system Ongoing treatment with rifampicin, carbamazepine or barbiturates
研究组 & 干预措施
diclofenac
Active Comparator
干预措施: Diclofenac (Drug)
sugar pill
Placebo Comparator
干预措施: sugar pill (Drug)
结局指标
主要结局
Suicide Assessment Scale (differences in scores before and after treatment)
时间窗: four weeks of treatment
次要结局
- Montgomery Asberg Rating Scale (differences in scores before and after treatment)(four weeks of treatment)
- Montgomery Asberg depression Ratin scale (changes in suicidality item before and after treatment)(four weeks of treatment)
- Comprehensive Psychopathological Rating Scale (changes in aggressive feelings item before and after treatment)(four weeks of treatment)
- Comprehensive Psychopthological Rating Scale (changes in fatigue item before and after treatment)(four weeks of treatment)
- Barratt Impulsiveness Scale (differences in scores before and after treatment)(four weeks of treatment)
- Montgomery Asberg Rating Scale (changes in concentration item before and after treatment)(four weeks of treatment)
研究者
研究点 (1)
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