ADHD and related depression symptoms Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Has a previous diagnosis of ADHD given by a UK psychiatrist 2. Scores 14 or more on Part A of the ASRS 3. Scores 5 or more on the PHQ-9 test, either with or without a previous depression diagnosis 4. Willing and able to give informed consent for participation in the trial 5. Male or female, aged 18 and over 6. In the Investigator’s opinion, is able and willing to comply with all trial requirements 7. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial
Exclusion criteria
Exclusion criteria: 1. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial 2. Significant known history of renal or hepatic impairment 3. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial 4. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 5. Already on a ketogenic, low carbohydrate (under 100g per day), vegetarian, or vegan diet 6. Has been diagnosed with anorexia nervosa or bulimia 7. Low BMI (<18.5kg/m²) 8. Has a bipolar disorder or schizophrenia diagnosis, or has experienced psychosis 9. Has type 1 diabetes 10. Acutely suicidal, and/or has engaged in self-injurious behaviour within the past two months 11. Active substance misuse or alcohol dependence, defined as scoring two or more on the CAGE questionnaire, any use of class A drugs in the past three months, or any use of cannabis in the last month 12. Has serious food allergies (experiencing food hypersensitivity that leads to anaphylaxis or other severe symptoms, which may require hospitalisation or are life-threatening) or otherwise requires a special diet that cannot be accommodated within a ketogenic diet, such as phenylketonuria 13. Treated with insulin, sulfonylureas, meglitinides, GLP-1 analogues, or SGLT2 inhibitors 14. Has gallstones, cholecystectomy, cachexia, porphyria, renal tubular acidosis, kidney stones, small bowel malabsorption, or a history of pancreatitis 15. Has no access to cooking facilities or ingredients to make appropriate recipes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD symptoms measured using the Adult Attention-Deficit/Hyperactivity Disorder Self-Report Scale (ASRS) at baseline and end of week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Previous key secondary outcomes as of 28/07/2026: 1. Metabolic wellness is measured using daily fasted capillary ß-hydroxybutyrate (BHB) and blood glucose (BG) readings with a Keto Mojo device, and venous mitochondrial-driven Metabolic Dysfunction Risk Testing (MitoGENE), advanced lipid panel, and comprehensive metabolic panel at baseline and end of week 16 2. Mood, energy, and clarity of thought are measured using self-reported ecological momentary assessments (EMAs) rated 0 to 10 daily throughout the study 3. Productivity, effectiveness, and procrastination are measured using self-reported ecological momentary assessments (EMAs) rated 0 to 10 weekly throughout the study 4. ADHD symptoms are measured using the Adult Attention-Deficit/Hyperactivity Disorder Self-Report Scale (ASRS) at baseline and end of week 6 5. Depression symptoms are measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and end of week 16 6. Early changes in depression symptoms are measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and end of week 6 7. Anxiety symptoms are measured using the Generalized Anxiety Disorder 7-item scale (GAD-7) at baseline and end of week 16 8. Early changes in anxiety symptoms are measured using the Generalized Anxiety Disorder 7-item scale (GAD-7) at baseline and end of week 6 9. Work and day-to-day performance are measured using the Work and Social Adjustment Scale (WSAS) at baseline and end of week 16 10. Early changes in work performance are measured using the Work and Social Adjustment Scale (WSAS) at baseline and end of week 6 11. Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and end of week 16 12. Early changes in sleep quality are measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and end of week 6 13. Baseline thyroid function is measured using blood level of Thyroid Stimulating Hormone (TSH) at baseline 14. Personality traits are measured u | — |
Countries
United Kingdom