BRILiANT mood study

Not Applicable

Completed

• Conditions: Dementias and Neurodegenerative Diseases and Depression; Mental and Behavioural Disorders; Depressive episode, unspecified

• Registration Number: ISRCTN64524251
• Lead Sponsor: Gateshead Health NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-06
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures