BRILiANT mood study
| ISRCTN | ISRCTN64524251 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64524251 |
| Secondary identifying numbers | 13284 |
- Submission date
- 06/12/2012
- Registration date
- 06/12/2012
- Last edited
- 06/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Jennie Parker
Scientific
Scientific
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 |
Study information
| Study design | Randomised interventional treatment study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised pilot trial of Blood pressure Rapid Intensive Lowering And Normal Treatment for mood and cognition in persistent depression |
| Study acronym | BRILiANT |
| Study objectives | This small, pilot study will look into whether rapid intensive lowering of blood pressure, in addition to participants 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(s) | First MREC, 28/08/2012, ref: 12/NE/0292 |
| Health condition(s) or problem(s) studied | Dementias and Neurodegenerative Diseases and Depression |
| Intervention | Participants are randomised to receive either rapid or standard blood pressure lowering treatment. |
| Intervention type | Other |
| Primary outcome measure | Depression score on the Montgomery-Asberg Depression Rating Scale (MDRS) measured at 12 weeks |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/02/2012 |
| Completion date | 29/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | UK Sample Size: 66 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 29/08/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Gateshead Health NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
England
United Kingdom
| Website | http://www.qegateshead.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01aye5y64 |
Funders
Funder type
Research council
Medical Research Council [MRC] (UK) ref: MR/J011835/1
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2015 | Yes | No |
