Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: a Clinical Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale
研究概览
简要总结
The purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than the treatment with alprazolam alone.
详细描述
We have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments that those who did not. There are also some scientific studies that included physical exercise in the treatment for panic disorder and compared them to other single pharmacological treatments.
So our objective will be to compare the efficacy of a pharmacological monotherapy (alprazolam), that is one of the options for the pharmacological treatment of panic disorder, with other treatment such as the combination of aerobic physical exercise and alprazolam, and to determine if this combination results in a better therapeutic response.
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with panic disorder scored between 20 and 30 by the Hamilton Anxiety Rating Scale/
- •(Baseline scale scores were measured during the first interview and diagnoses were made by a psychiatrist using the Structured Clinical Interview for DSM IV).
- •Good physical health and normal results determined on a previous physical examination and routine laboratory tests (renal, hepatic, hematological and thyroid function).
- •Patients who completed a written informed consent form (which was obtained from every included patient and had been fully explained before the procedure).
排除标准
- •A history of some kind of recent somatic disease.
- •Diagnosis of some other type of associated or psychiatric disease of axis I of DSM IV, such as affective disorders, drug dependency.
- •Hamilton Anxiety Scale lower than 20 points or higher than
- •Use of some other type of medication or treatment (including psychotherapy) or having received it during last past 3 months.
- •Patients who could not complete the clinical examination
- •Patients who have not accepted to complete or sign the written informed consent.
- •Pregnant patients or in lactation. (A pregnancy test was performed for women in fertile age)
- •Patients with history of rejection to the used drug.
研究组 & 干预措施
Alprazolam
Patients assigned to the pharmacological plan
干预措施: Alprazolam (Drug)
Alprazolam + Aerobic exercise
Patients assigned to mix plan
干预措施: Alprazolam + Aerobic exercise (Drug)
结局指标
主要结局
Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale
时间窗: 12 weeks
The Hamilton Anxiety Rating Scale is a test that consists of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Each of the 14 items measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety)with a total score range of 0-56, where 17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.
次要结局
- Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)(Baseline and 12 weeks)
- Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)(Baseline and 12 weeks)
研究者
Dr.Marcelo Rudelir
Ph D
University of Buenos Aires