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ISRCTN
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ISRCTN64524251
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DOI
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10.1186/ISRCTN64524251
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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BRILiANT mood study
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Scientific title
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Randomised pilot trial of Blood pressure Rapid Intensive Lowering And Normal Treatment for mood and cognition in persistent depression
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Acronym
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BRILiANT
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Serial number at source
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13284
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Study hypothesis
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This small, pilot study will look into whether rapid intensive lowering of blood pressure, in addition to participant’s regular antidepressant treatment, would help further improve their depression, and determine the feasibility of running a larger study involving more people at a later date. It will involve 66 people from the Northumberland, Tyne and Wear area aged between 50 and 80 years of age, with depression and raised blood pressure requiring further treatment. Participants will have up to eight visits at the Clinical Ageing Research Unit (CARU), Newcastle upon Tyne. All participants will continue with their usual antidepressants and be randomly allocated to receive either standard blood pressure treatment or intensive blood pressure treatment. Everyone will receive treatment for their blood pressure. Participants will complete questionnaires including a Beck Depression Inventory (BDI) every two weeks and MDRS at baseline, 6 and 12 weeks. A detailed neuropsychological battery and MRI scan will take place at baseline and the final 12 week outcome only. Participants will be treated until 12 weeks when investigators blind to their treatment allocation will assess the outcome measures. All participants will have their BP and depression managed by the study team throughout the trial to ensure fidelity to the treatment regimes.
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Lay summary
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Not provided at time of registration
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Ethics approval
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First MREC, 28 August 2012 ref: 12/NE/0292
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Study design
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Randomised interventional treatment study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Dementias and Neurodegenerative Diseases and Depression
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/02/2012
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Anticipated end date
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29/08/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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UK Sample Size: 66;
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Interventions
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Participants are randomised to receive either rapid or standard blood pressure lowering treatment.
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Primary outcome measure(s)
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Depression score on the Montgomery-Asberg Depression Rating Scale (MDRS) measured at 12 weeks
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Medical Research Council [MRC] (UK) ref: MR/J011835/1
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Trial website
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Publications
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Contact name
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Mrs
Jennie
Parker
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Address
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Newcastle University
Institute of Health and Society
4th Floor
William Leech Building
Framlington Place
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City/town
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Newcastle Upon Tyne
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Zip/Postcode
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NE2 4HH
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Country
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United Kingdom
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Email
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jennie.parker@ncl.ac.uk
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Sponsor
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Gateshead Health NHS Foundation Trust (UK)
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Address
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Queen Elizabeth Hospital
Sheriff Hill
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City/town
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Gateshead
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Zip/Postcode
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NE9 6SX
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Country
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United Kingdom
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Sponsor website:
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http://www.qegateshead.nhs.uk/
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Date applied
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06/12/2012
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Last edited
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06/12/2012
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Date ISRCTN assigned
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06/12/2012
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