A Randomized, Controlled Trial on the Effects of Paroxetine Versus Placebo in Combination With Aerobic Exercise or Relaxation Training in the Treatment of Panic Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
研究概览
简要总结
Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination with regular aerobic exercise (running) or regular relaxation training in the treatment of panic disorder.
详细描述
In continuation of prior work from our group (Broocks A, Bandelow B, Pekrun G, et al. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry 1998; 155(5):603-9.) it is the purpose of this trial to test the assumed superiority of a combined therapy of paroxetine and aerobic exercise compared to placebo or unspecific relaxation training in panic disorder. Participants were randomized to a 10 week treatment protocol of paroxetine 40 mg daily or placebo in combination with regular exercise or regular relaxation after having given informed consent and screening of in- and exclusion criteria.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Panic disorder with or without agoraphobia due to DSM-IV
- •Written informed consent
- •Score of 17 or more on the P&A scale
- •Score on the CGI of 4 or more (markedly ill)
排除标准
- •Pregnancy, lactating or insufficient contraception (pearl index >1)
- •Other psychiatric disorders such as psychoses, addictive disorders, dementia, etc.
- •Clinically relevant abnormalities in physical examination or laboratory results
- •Prior major depression or bipolar disorder
- •Suicidality
- •psychotropic medication other than promethazine
- •current psychological treatment
- •unable to perform regular aerobic exercise
研究组 & 干预措施
1
Paroxetine + aerobic exercise
干预措施: paroxetine + aerobic exercise (Drug)
2
Paroxetine + relaxation
干预措施: Paroxetine + relaxation (Drug)
3
Placebo + aerobic exercise
干预措施: Placebo + aerobic exercise (Drug)
4
Placebo + relaxation
干预措施: Placebo + relaxation (Drug)
结局指标
主要结局
Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
时间窗: Baseline to endpoint (10 weeks)
Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)
时间窗: Baseline to endpoint (10 weeks)
次要结局
- Symptom severity due to Hamilton Anxiety Scale (HAMA)(Baseline to endpoint (10 weeks))
- Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)(Baseline to endpoint (10 weeks))
- Response and remission analysis between groups(LOCF-analysis)