Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03667677
• Other study ID #: CES-TAHA
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: November 2018
• Source: Chongqing Medical University
• Contact: Peng Xie
• Phone: 86-023-68485490
• Email: xiepeng[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: July 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?-?);

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Hypertension

Intervention

Drug:
• Tandospirone + Amlodipine
The first group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).
• Tandospirone placebo + Amlodipine
The second group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).
• Tandospirone + Amlodipine placebo
The third group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).
• Tandospirone placebo + Amlodipine placebo
The fourth group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).

Locations

Country	Name	City	State
China	Beijing Friendship Hospital of Capital Medical University	Beijing	Beijing
China	Beijing Haidian Section of Peking University Third Hospital	Beijing	Beijing
China	Xuanwu Hospital of Capital Medical University	Beijing	Beijing
China	Yongchuan Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Zhongda Hospital of Southeast University	Nanjing	Giangsu
China	the First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Kailuan General Hospital	Tangshan	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Office systolic blood pressure and diastolic blood pressure		Change from Baseline Office systolic blood pressure and diastolic blood pressure at 4 weeks and 8 weeks
Primary	14-item Hamilton Anxiety Scale(HAMA)	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.	Change from Baseline HAMA score at 4 weeks and 8 weeks
Secondary	the proportion of patients who met blood pressure control goal( < 140/90mmHg)		Week 8
Secondary	24-hour ambulatory blood pressure monitoring(ABPM)		Change from Baseline ABPM at 4 weeks and 8 weeks
Secondary	the proportion of participants with an at least 50% reduction of HAMA score from baseline		Week 8
Secondary	the proportion of participants showing 7 or less on HAMA		Week 8
Secondary	20-item Self-Rating Anxiety Scale(SAS)	SAS-20 are rated on 4 grades ranging from 1(a little of the time) to 4(most of the time).The standard score ranges are 25-49 (normal range), 50-59 (mild anxiety), 60-69(moderate anxiety), and 70 or more(severe anxiety).	Change from Baseline SAS score at 4 weeks and 8 weeks
Secondary	heart rate variability(HRV)		Change from Baseline HRV at 4 weeks and 8 weeks
Secondary	17-item Hamilton Depression Rating Scale(HAMD)	HAMD-17 are rated on 5 grades ranging from 0 (no symptom) to 4 (very severe). 7 or less on HAMD means no depression, 7 to 17 on HAMD means mild depression, 18 to 23 on HAMD means moderate depression, and 24 or more on HAMD means severe depression.	Change from Baseline HAMD score at 4 weeks and 8 weeks
Secondary	Clinical Global Impression-Improvement(CGI-I)		Change from Baseline CGI-I score at 4 weeks and 8 weeks
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire(Q-LES-Q)	Q-LES-Q are rated on 5 grades ranging from 1 to 5 points.	Change from Baseline Q-LES-Q score at 4 weeks and 8 weeks