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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Tandospirone + Amlodipine |
|
| Group 2 | Experimental | Tandospirone placebo + Amlodipine |
|
| Group 3 | Experimental | Tandospirone + Amlodipine placebo |
|
| Group 4 | Placebo Comparator | Tandospirone placebo + Amlodipine placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandospirone + Amlodipine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of patients who met blood pressure control goal( < 140/90mmHg) | Week 8 | |
| 24-hour ambulatory blood pressure monitoring(ABPM) | Change from Baseline ABPM at 4 weeks and 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Xie | Contact | 86-023-68485490 | xiepeng@cqmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital of Capital Medical University | Beijing | Beijing Municipality | China | |||
| Beijing Haidian Section of Peking University Third Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24433257 | Background | 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. | |
| 25960656 | Background | 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. |
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Any public report on the results of this study will not disclose personal information of the participants.
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| Tandospirone placebo + Amlodipine | Drug | 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 | Drug | 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 | Drug | 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). |
|
| the proportion of participants with an at least 50% reduction of HAMA score from baseline |
| Week 8 |
| the proportion of participants showing 7 or less on HAMA | Week 8 |
| 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 |
| heart rate variability(HRV) | Change from Baseline HRV at 4 weeks and 8 weeks |
| 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 |
| Clinical Global Impression-Improvement(CGI-I) | Change from Baseline CGI-I score at 4 weeks and 8 weeks |
| 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 |
| Beijing |
| Beijing Municipality |
| China |
| Xuanwu Hospital of Capital Medical University | Beijing | Beijing Municipality | China |
| Yongchuan Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Zhongda Hospital of Southeast University | Nanjing | Giangsu | China |
| Kailuan General Hospital | Tangshan | Hebei | China |
| the First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| 25164965 | Background | 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. |
| 24987456 | Background | 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. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C055267 | tandospirone |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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