NCT01496690已完成4 期
Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Scale
研究概览
简要总结
The PACS study aims to investigate the efficacy and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety.
The study design is an 8 week flexible dosage, randomized placebo controlled.
The study population is patients diagnosed with ICD-10 schizophrenia and age 18-65. Patients are recruited from outpatient clinics from entire Denmark.
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
- •Ages 18-65 years
- •An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9
- •Stable dosage of psychotropic 4 weeks before inclusion
- •Hamilton Anxiety Scale total score > 15
- •Positive and Negative Syndrome Scale for Schizophrenia total score < 70
- •The Calgary Depression Scale for Schizophrenia total score < 10
- •Fertile women: Contraception during the trial
- •S-creatinin within normal reference range
- •Signed informed consent and power of attorney
排除标准
- •Significant substance abuse
- •QTc > 480 milliseconds
- •Severe dysregulated diabetes
- •For women: Pregnancy or breast-feeding
- •Confinement in accordance with the Danish Law of Psychiatry
- •Concrete suicidally
- •Known hypersensitivity or allergic reaction to the active ingredient of the drug
研究组 & 干预措施
pregabalin
Active Comparator
The pregabalin dose is 75 mg daily the first week followed by 7 weeks of flexible daily dosing (150, 300, 450 or 600 mg.) depending on tolerability and response.
干预措施: Pregabalin (Drug)
Pregabalin Placebo Capsules
Placebo Comparator
干预措施: Pregabalin Placebo Capsules (Drug)
结局指标
主要结局
Hamilton Anxiety Scale
时间窗: Baseline - 4 weeks treatment - 8 weeks treatment
次要结局
- UKU-Overall adverse effect scale(Baseline - 4 weeks treatment - 8 weeks treatment)
研究者
研究点 (1)
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