Clinical trial NCT03667677: Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety
Official title: Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety: a Multicentre, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Anxiety
Keywords: Hypertension
Anxiety
Tandospirone
Amlodipine
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. An age of 60 - 80 years old;
2. 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;
3. A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder;
4. Informed consent signed.

Exclusion Criteria:

1. Secondary hypertension;
2. Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg
3. Hypertension with target organ damage;
4. 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);
5. Diabetes and dyslipidemia;
6. Asthma, chronic obstructive pulmonary disease, bronchiectasis, and respiratory failure;
7. Inflammatory bowel disease, active gastritis, pancreatitis, partial or complete intestinal obstruction, and chronic diarrhea;
8. 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);
9. Uncontrolled thyroid diseases;
10. Severe or unstable central nervous system diseases;
11. Schizophrenia, bipolar disorder, severe intellectual disability, or severe cognitive impairment;
12. Having been diagnosed with alcohol or drug abuse within the past 1 year;
13. Presenting the risk of suicide, self-injury, and hurt others;
14. Having participated in other clinical studies within the past 3 months;
15. Having been treated with anxiolytics, antidepressants, antipsychotics within the past 4 weeks, or have contraindications to the study medications.
16. Breastfeeding, pregnancy, or a pregnancy plan during the study;
17. Other diseases which the responsible clinician judged that a change in current therapy would place the participant at risk.

Primary outcomes:
measure: Office systolic blood pressure and diastolic blood pressure
timeFrame: Change from Baseline Office systolic blood pressure and diastolic blood pressure at 4 weeks and 8 weeks
measure: 14-item Hamilton Anxiety Scale(HAMA)
timeFrame: Change from Baseline HAMA score at 4 weeks and 8 weeks
Secondary outcomes:
measure: the proportion of patients who met blood pressure control goal( < 140/90mmHg)
timeFrame: Week 8
measure: 24-hour ambulatory blood pressure monitoring(ABPM)
timeFrame: Change from Baseline ABPM at 4 weeks and 8 weeks
measure: the proportion of participants with an at least 50% reduction of HAMA score from baseline
timeFrame: Week 8
measure: the proportion of participants showing 7 or less on HAMA
timeFrame: Week 8
measure: 20-item Self-Rating Anxiety Scale(SAS)
timeFrame: Change from Baseline SAS score at 4 weeks and 8 weeks
measure: heart rate variability(HRV)
timeFrame: Change from Baseline HRV at 4 weeks and 8 weeks
measure: 17-item Hamilton Depression Rating Scale(HAMD)
timeFrame: Change from Baseline HAMD score at 4 weeks and 8 weeks
measure: Clinical Global Impression-Improvement(CGI-I)
timeFrame: Change from Baseline CGI-I score at 4 weeks and 8 weeks
measure: Quality of Life Enjoyment and Satisfaction Questionnaire(Q-LES-Q)
timeFrame: Change from Baseline Q-LES-Q score at 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital of Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Haidian Section of Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Yongchuan Hospital of Chongqing Medical University
state: Chongqing
city: Nanjing
country: China
facility: Zhongda Hospital of Southeast University
state: Giangsu
city: Tangshan
country: China
facility: Kailuan General Hospital
state: Hebei
city: Taiyuan
country: China
facility: the First Affiliated Hospital of Shanxi Medical University
state: Shanxi
Study officials:
References:
citation: Bhattacharya R, Shen C, Sambamoorthi U. Excess risk of chronic physical conditions associated with depression and anxiety. BMC Psychiatry. 2014 Jan 16;14:10. doi: 10.1186/1471-244X-14-10.
citation: Pan Y, Cai W, Cheng Q, Dong W, An T, Yan J. Association between anxiety and hypertension: a systematic review and meta-analysis of epidemiological studies. Neuropsychiatr Dis Treat. 2015 Apr 22;11:1121-30. doi: 10.2147/NDT.S77710. eCollection 2015.
citation: Byrd JB, Brook RD. Anxiety in the "age of hypertension". Curr Hypertens Rep. 2014 Oct;16(10):486. doi: 10.1007/s11906-014-0486-0.
citation: Kretchy IA, Owusu-Daaku FT, Danquah SA. Mental health in hypertension: assessing symptoms of anxiety, depression and stress on anti-hypertensive medication adherence. Int J Ment Health Syst. 2014 Jun 21;8:25. doi: 10.1186/1752-4458-8-25. eCollection 2014.