Condition category
Mental and Behavioural Disorders
Date applied
06/12/2012
Date assigned
06/12/2012
Last edited
06/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jennie Parker

ORCID ID

Contact details

Newcastle University
Institute of Health and Society
4th Floor
William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
-
jennie.parker@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13284

Study information

Scientific title

Randomised pilot trial of Blood pressure Rapid Intensive Lowering And Normal Treatment for mood and cognition in persistent depression

Acronym

BRILiANT

Study hypothesis

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.

Ethics approval

First MREC, 28/08/2012, ref: 12/NE/0292

Study design

Randomised interventional treatment study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dementias and Neurodegenerative Diseases and Depression

Intervention

Participants are randomised to receive either rapid or standard blood pressure lowering treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Depression score on the Montgomery-Asberg Depression Rating Scale (MDRS) measured at 12 weeks

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/02/2012

Overall trial end date

29/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 66

Participant exclusion criteria

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

Recruitment start date

01/02/2012

Recruitment end date

29/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Gateshead Health NHS Foundation Trust (UK)

Sponsor details

Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.qegateshead.nhs.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council [MRC] (UK) ref: MR/J011835/1

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-015-0042-y

Publication citations

Additional files

Editorial Notes