Anxiety, Hypertension
Conditions
Keywords
Hypertension, Anxiety, Tandospirone, Amlodipine
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.
Interventions
DRUGTandospirone + 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).
DRUGTandospirone 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).
DRUGTandospirone + 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).
DRUGTandospirone 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).
Sponsors
Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Change from Baseline SAS score at 4 weeks and 8 weeks | 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). |
| 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 | 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. |
| 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) | Change from Baseline Q-LES-Q score at 4 weeks and 8 weeks | Q-LES-Q are rated on 5 grades ranging from 1 to 5 points. |
| 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 | — |
Countries
China
Contacts
Primary ContactPeng Xie
Outcome results
None listed