Randomized Controlled Trial of Pharmacotherapy for Anxiety in Hypertensive Patients on Multiple Antihypertensive Drugs
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change in anxiety symptoms as assessed by Hamilton Anxiety Rating scale (HAM-A).
研究概览
简要总结
Our research project titled Randomized Controlled Trial of Pharmacotherapy for Anxiety in Hypertensive Patients on Multiple Antihypertensive Drugs has been
designed with a background that anxiety is an under treated and under diagnosed problem in patients of hypertension who are taking multiple antihypertensive drugs. The aim of our study is to assess the efficacy of anxiety pharmacotherapy in such a population in managing anxiety symptoms and its effect on blood pressure control and quality of life.
We hope to provide evidence for management of anxiety in patients with hypertension on multiple anti-hypertensive drugs.
Future directions: long term follow up will be needed of these patients to evaluate for sustained effect and explore for possible treatment alternatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria:
- •Hypertensive patients on at least 2 anti hypertensives.
- •Diagnosed with generalized anxiety disorder according to the DSM-5 criteria 3.Patient in the mild to moderate category of GAD (HAM A less than 25).
排除标准
- •Exclusion criteria:
- •Patients with functional disability due ot anxiety.
- •Long QTc on Baseline ECG, or concomitant QTc prolonging drugs.
- •Patients with a primary psychiatric diagnosis other than anxiety disorder will be excluded, including patients with MDD (major depressive diorder), PTSD (post traumatic stress disorder), OCD (obsessive compulsive disorder), or any of the following DSM-5 diagnoses: 1) Dementia, delirium; 2) Schizophrenia, Schizoaffective, or other psychotic disorder; 3) Psychotic features including any delusions or hallucinations.
- •Patients with secondary causes of hypertension.
- •Current alcohol or other substance abuse disorder.
- •Patient taking herbal supplements.
- •Pregnant and lactating females will be excluded.
结局指标
主要结局
Change in anxiety symptoms as assessed by Hamilton Anxiety Rating scale (HAM-A).
时间窗: 4 weeks, 12 weeks
次要结局
- Change in blood pressure control(4 weeks, 12 weeks)
- adverse events(4 weeks, 12 weeks)
- change in quality of life assessed by WHOQOL-BREF questionnaire(4 weeks, 12 weeks)
研究者
Daksh Bansal
AIIMS New Delhi