ISRCTN64524251已完成未知
Randomised pilot trial of Blood pressure Rapid Intensive Lowering And Normal Treatment for mood and cognition in persistent depression
Gateshead Health NHS Foundation Trust (UK)0 个研究点目标入组 66 人开始时间: 2012年12月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •We will identify older adults (aged 50-80) with a history of Major Depressive Disorder (MDD) with persistent depressive symptoms who also have inadequately treated hypertension. Subjects will have a history of MDD with Hamilton depression rating scale (HAMD) at baseline = 15, be 50 to 80 years old and currently have a BP >140/90 mmHg (threshold recommended by NICE for treatment if 10 year cardiovascular risk > 20% or symptomatic vascular disease).
- •1. Aged 50-80 (to minimise risk of including people with dementia or pre-dementia)
- •2. DSM-IV defined MDD will be assessed using SCID by trained staff. Study subjects will have a history of MDD and have current clinically important depressive symptoms (HAMD>15); they will not therefore be in remission and so will have scope for significant improvement in the trial. We will recruit subjects stable on single antidepressant therapy after at least 2 months at a standard dose. As in other depression studies the HAMD will be used for defining the study population but not as an outcome measure. The primary outcome measure will be the Montgomery Asberg Depression Rating Scale.
- •3. All subjects will have hypertension, defined as having a BP>140/90mmHg recorded as the average of the second and third of three seated BP measurements taken in the left arm at 5 minute intervals. Patients with treated hypertension may enter the study if they are taking only one BP lowering drug and their BP is >140/90mmHg.
- •4. MMSE >23
- •5. Medically stable (including no change in medication in the last month)
- •6. Patient has provided written informed consent for participation in the study prior to any site specific procedures
- •7. Male or female participants
排除标准
- •1. Any other DSM-IV Axis I disorder other than an anxiety disorder unless the depressive episode is considered to be secondary to the anxiety disorder, confirmed using the Structured Clinical Interview for DSM (SCID)
- •2. Dependence or harmful use of alcohol or other drug in the past 12 months
- •3. Taking two or more antihypertensive drugs
- •4. Clinical evidence of dementia
- •5. History or evidence from neurological examination of clinical stroke
- •6. History of bipolar or psychotic disorder
- •7. Severe renal or hepatic impairment
- •8. Pregnancy or planning to become pregnant within next 12 months or breast feeding
- •9. Use of other investigational study drugs within 30 days prior to study entry (defined as date of randomisation into study)
- •10. Previous participation in this study
- •11. Presence of cardiac pacemaker or other contraindications to MRI
研究者
相似试验
已完成
2 期
Evaluation of blood pressure and heart rate by injecting epinephrine containing local anesthetiaIRCT2017040533235N1Vice chancellor for research of Mazandaran University of Medical Sciences100
已完成
不适用
Pilot testing of a new Blood Pressure measuring device on healthy adult volunteersmeasurement of blood pressureCardiovascular - Normal development and function of the cardiovascular systemACTRN12617000774325Monash University45
进行中（未招募）
不适用
A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure – A Pilot Study (PRONTO) - PRONTOacute heart failure and elevated BP (systolic blood pressure [SBP] =160 mm Hg) requiring parenteral IV antihypertensive therapyMedDRA version: 9.1Level: LLTClassification code 10000803Term: Acute heart failureMedDRA version: 9.1Level: LLTClassification code 10020772Term: HypertensionEUCTR2008-003676-22-DEThe Medicines Company140
尚未招募
不适用
Clinical trials for children's accuracy studies using an automatic blood pressure gauge with a stethoscope according to the protocol presented by the International Organization for StandardizatioDiseases of the circulatory systemKCT0007674Korea University Anam Hospital35
尚未招募
不适用
A clinical trial for the study of the accuracy of the general public using an automatic blood pressure gauge with stethoscope according to the protocol presented by the International Organization for StandardizatioKCT0007753Korea University Anam Hospital100