£7.9M ENERGISE-BD trial to explore diet to reduce depression in bipolar disorder

A major new clinical trial will compare two dietary approaches, nutritional ketosis diet and the NHS EatWell guidelines in patients with bipolar depression.

The University of Birmingham is proud to partner with the University of Edinburgh as co-leads on ENERGISE‑BD, a major new clinical trial funded by Wellcome.

The study, Evaluating Nutritional Ketosis Versus NHS EatWell Guidelines for Bipolar Depression: Single Blind Phase III Randomised Controlled Trial, will compare the effects of two dietary approaches on depressive symptoms in people with bipolar disorder: a nutritional ketosis diet and the NHS EatWell guidelines.

Bringing together two leading institutions, ENERGISE‑BD addresses an important gap in mental health treatment research. The trial is jointly led by Professor Rebecca Reynolds and Professor Daniel Smith in Edinburgh, and Professors Steven Marwaha and Matthew Broome in Birmingham. Birmingham and Solihull Mental Health NHS Foundation Trust is a key delivery partner, with the Edinburgh Clinical Trials Unit providing expertise in trial design, delivery, and statistical oversight.

The ENERGISE-BD trial represents a significant step forward in understanding how dietary interventions can support mental health. By comparing two well-defined nutritional strategies in a rigorous randomised controlled trial, the study aims to generate evidence that could reshape clinical practice and public health guidance, offering new hope to individuals affected by bipolar depression.

ENERGISE-BD represents a pivotal methodologically robust study in evaluating whether a specific dietary intervention such as a ketogenic diet can help resolve depression in people with bipolar disorder. Showing whether this type of diet can be used by the very diverse, multicultural patient groups we serve in Birmingham is a key and exciting part of the trial.

Professor Steven Marwaha, University of Birmingham

We welcome Wellcome’s investment in this clinical trial comparing two nutritional interventions for bipolar depression. Building on our recent feasibility study of the ketogenic diet, this work will also examine how these nutritional approaches affect brain metabolism. If effective, a nutritional treatment for bipolar depression would represent a major breakthrough.

Professor Daniel Smith, University of Edinburgh

We are pleased to collaborate on this ground-breaking trial testing whether bipolar depression can be managed through dietary intervention. Edinburgh Clinical Trials Unit will implement and oversee the study, providing trial design, delivery, data systems and statistical expertise, to ensure the research is conducted to the highest scientific standards.

Dr Aryelly Rodriguez, ENERGISE-BD Trial Statistician at Edinburgh Clinical Trials Unit

Professors Marwaha and Broome are Co-director and Director of the Mental Health Mission Midlands Translational Centre. A major focus of the Centre is to accelerate mental health research across the Midlands, leveraging regional infrastructure, and to develop and test novel and innovative treatments focused on helping people with major mood disorders such as bipolar disorder. This makes ENERGISE-BD a flagship initiative within its mission.