Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety: a Multicentre, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 256
- 试验地点
- 7
- 主要终点
- Office systolic blood pressure and diastolic blood pressure
研究概览
简要总结
This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.
详细描述
In recent years, many studies have found that elevated blood pressure is associated with anxiety. It has been report that the incidence of hypertension with anxiety is 25%-54%. The studies have confirmed that anxiety can significantly reduce the antihypertensive effect. Therefore, anxiolytics can increase the antihypertensive effect in patients with hypertension and anxiety. However, there is currently no standard treatment for patients with hypertension and anxiety, and few clinical studies have focused on the treatment of these neglected patients. Improvement on hypertension through relieving anxiety and relief of anxiety through lowering hypertension are lack of clinical studies to prove. This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.
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
- •An age of 60 - 80 years old;
- •Mild or moderate hypertension diagnosed in previous or at screening (office systolic blood pressure ≥ 140 mm Hg and ≤ 180 mm Hg, or diastolic blood pressure ≥ 90 mm Hg and ≤ 110 mm Hg, or both, on three readings on separate days when not taking any blood pressure drugs) ,and the blood pressure still meet the above criteria after the run-in period;
- •A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder;
- •Informed consent signed.
排除标准
- •Secondary hypertension;
- •Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg
- •Hypertension with target organ damage;
- •Cerebral hemorrhage, ischemic cerebral infarction, coronary artery disease, myocardial infarction, second-degree or third-degree atrioventricular block, sick sinus syndrome, atrial fibrillation, left ventricular hypertrophy, cardiac insufficiency (NYHA class Ⅱ-Ⅳ);
- •Diabetes and dyslipidemia;
- •Asthma, chronic obstructive pulmonary disease, bronchiectasis, and respiratory failure;
- •Inflammatory bowel disease, active gastritis, pancreatitis, partial or complete intestinal obstruction, and chronic diarrhea;
- •Acute or chronic hepatitis, hepatic insufficiency (ALT or AST is more than 2 times the upper limit of normal), and renal insufficiency (serum creatinine > 130 umol / L);
- •Uncontrolled thyroid diseases;
- •Severe or unstable central nervous system diseases;
- •Schizophrenia, bipolar disorder, severe intellectual disability, or severe cognitive impairment;
- •Having been diagnosed with alcohol or drug abuse within the past 1 year;
- •Presenting the risk of suicide, self-injury, and hurt others;
- •Having participated in other clinical studies within the past 3 months;
- •Having been treated with anxiolytics, antidepressants, antipsychotics within the past 4 weeks, or have contraindications to the study medications.
- •Breastfeeding, pregnancy, or a pregnancy plan during the study;
- •Other diseases which the responsible clinician judged that a change in current therapy would place the participant at risk.
研究组 & 干预措施
Group 1
Tandospirone + Amlodipine
干预措施: Tandospirone + Amlodipine (Drug)
Group 2
Tandospirone placebo + Amlodipine
干预措施: Tandospirone placebo + Amlodipine (Drug)
Group 3
Tandospirone + Amlodipine placebo
干预措施: Tandospirone + Amlodipine placebo (Drug)
Group 4
Tandospirone placebo + Amlodipine placebo
干预措施: Tandospirone placebo + Amlodipine placebo (Drug)
结局指标
主要结局
Office systolic blood pressure and diastolic blood pressure
时间窗: Change from Baseline Office systolic blood pressure and diastolic blood pressure at 4 weeks and 8 weeks
14-item Hamilton Anxiety Scale(HAMA)
时间窗: Change from Baseline HAMA score at 4 weeks and 8 weeks
HAMA-14 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 56. 29 or more on HAMA means severe anxiety disorders, 21 to 28 on HAMA means obvious anxiety disorders, 14 to 20 on HAMA means anxiety disorders, 8 to 13 on HAMA means suspicious anxiety disorders, 7 or less means no anxiety disorders.
次要结局
- the proportion of participants showing 7 or less on HAMA(Week 8)
- the proportion of patients who met blood pressure control goal( < 140/90mmHg)(Week 8)
- 17-item Hamilton Depression Rating Scale(HAMD)(Change from Baseline HAMD score at 4 weeks and 8 weeks)
- Quality of Life Enjoyment and Satisfaction Questionnaire(Q-LES-Q)(Change from Baseline Q-LES-Q score at 4 weeks and 8 weeks)
- Clinical Global Impression-Improvement(CGI-I)(Change from Baseline CGI-I score at 4 weeks and 8 weeks)
- 20-item Self-Rating Anxiety Scale(SAS)(Change from Baseline SAS score at 4 weeks and 8 weeks)
- heart rate variability(HRV)(Change from Baseline HRV at 4 weeks and 8 weeks)
- 24-hour ambulatory blood pressure monitoring(ABPM)(Change from Baseline ABPM at 4 weeks and 8 weeks)
- the proportion of participants with an at least 50% reduction of HAMA score from baseline(Week 8)
研究者
Xie Peng
Professor of Neurology, Yongchuan Hospital of Chongqing Medical University
Chongqing Medical University