Abstract
BackgroundThe blood pressure rapid intensive lowering and normal treatment for mood and cognition in persistent depression (BRILiANT mood study) was devised as a pilot study to investigate the feasibility and safety of intensive blood pressure lowering as treatment for persistent mood and cognitive symptoms in older adults with major depressive disorder and to assess the availability of this population for recruitment. In addition, the relationship between reduced blood pressure and the change in cerebral blood flow and mood was to be investigated.MethodsA single centre pilot randomised controlled trial (RCT), with two parallel groups of intensive or normal treatment for hypertension, recruiting from primary and secondary care and newspaper advert, with an aim of recruiting 66 participants, was observed in this study. At the end of the recruitment period, in order to explore the reasons for failure to recruit to target, surveys were developed and issued to those involved in recruitment.ResultsRecruitment rates were lower than expected which led to the study being expanded to further areas and opened to self-referral via advertisement. However, because of better management of hypertension due to changes in the UK Quality and Outcomes Framework guidelines for blood pressure treatment, few eligible patients were identified and the study closed at the end of the recruitment period, with 13 participants consenting, but 12 failing screening resulting in one recruited participant.ConclusionsOverall, the BRILiANT mood study was found not to be feasible, and results suggest that the expected patient population no longer exists. To overcome such recruitment difficulties, a prompt commencement of a study after funding so no relevant care changes occur might help prevent similar problems in future studies. In addition, self-referral, in this case via advertisement in papers, may be a useful tool to increase response rate. When recruiting in primary care, direct access to primary care databases, in a secure and anonymised way, may enable more effective screening. Ultimately, the BRILiANT mood study was shown not to be feasible; this was a useful conclusion from this pilot study.Trial RegistrationISRCTN 64524251; UKCRN Portfolio No: 13284
Highlights
The blood pressure rapid intensive lowering and normal treatment for mood and cognition in persistent depression (BRILiANT mood study) was devised as a pilot study to investigate the feasibility and safety of intensive blood pressure lowering as treatment for persistent mood and cognitive symptoms in older adults with major depressive disorder and to assess the availability of this population for recruitment
Overall, the BRILiANT mood study was found not to be feasible, and results suggest that the expected patient population no longer exists
The BRILiANT mood study was shown not to be feasible; this was a useful conclusion from this pilot study
Summary
The blood pressure rapid intensive lowering and normal treatment for mood and cognition in persistent depression (BRILiANT mood study) was devised as a pilot study to investigate the feasibility and safety of intensive blood pressure lowering as treatment for persistent mood and cognitive symptoms in older adults with major depressive disorder and to assess the availability of this population for recruitment. Whilst factors causing symptom persistence in middle-aged and older adults is not fully understood, there is robust evidence that it is strongly related to cerebrovascular disease [9] and prospective studies of vascular diseases have reported that previous major depression or depressive symptoms predicts a two- to threefold increase in coronary heart disease and stroke disease [9]. MRI studies have reported reduced cerebral blood flow in older adults [22] with evidence that treatment can increase the blood flow suggesting that the adverse effects may be reversible [22]. Hypertension causes structural vascular adaptation with remodelling and hypertrophy leading to arteriolar luminal narrowing and wall thickening This leads to compromised cerebral blood flow (CBF). Evidence suggests that BP lowering to the normal range may reverse these changes, with two studies in hypertension reporting improved CBF at 6 months of BP lowering [25,26] and one found improved cognition as well [25]
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