Ketogenic Diet for Treatment-Resistant Depression: Dietary Interventions for MEntal Health Study (DIME)

NCT06091163 | Completed DMC

• 1 other identifier: R87397
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Depression is a debilitating chronic illness affecting 1 in 6 adults in the United Kingdom (UK) at any one time. Antidepressants and psychological therapy are the main treatments, but some people do not respond to these. Neurons and signals in the brain are greatly disrupted in people with severe depression. A ketogenic diet, a high-fat and very low-carbohydrate diet, supplies a form of energy that appears to help brain cells communicate and may improve the treatment of depression. Our goal is to find out whether a ketogenic diet could be an additional effective treatment for patients with depression for which antidepressants do not work. Using social media advertising, 100 patients, ages 18-65, who have previously tried at least two different antidepressant medications within the current depressive episode will be recruited. Enrolment, consent, and data collection will be collected online using self-report questionnaires. Participants will be allocated by minimisation 1:1 to the KD group or control group based on depressive severity (moderately severe vs. severe) and body mass index (\<30kg/m2 vs. 30+ kg/m2). The intervention group will receive 6-weeks of prepared ketogenic diet meals (3 meals with snacks per day) and weekly ketogenic diet-focused nutrition counselling. The control group will be asked to follow a diet to reduce their saturated fat intake and increase vegetable consumption by one portion a day. The control group will receive vouchers to assist with purchases and will be provided with weekly nutritional counselling. Existing treatment for depression will remain in both groups. The primary outcome is the change in depression symptoms at six weeks. All participants will complete assessments of depression and anxiety every two weeks, starting before treatment to post-intervention (week 6), and again at week 12. Additional outcomes include participants' ability to experience pleasure, quality of life, ability to socialise and work, cognitive processing, morning cortisol, and gut microbiome. At all stages of the study, adults with lived experience of depression will advise the research team to take into account the needs and views of patients. This study will provide evidence of whether following a ketogenic diet leads to a short-term improvement in depression in people whose depression cannot be relieved by antidepressants.

Conditions

Treatment Resistant Depression; Depression; Mental Illness; Mental Disorder; Depressive Disorder

Keywords

Ketogenic Diet; Keto Diet; Keto; Metabolic Ketosis; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  The PHQ-9 is a previously validated and reliably self-administered 9-item questionnaire of depression severity corresponding to Diagnostic Statistical Manual 5th Edition (DSM-V) criteria for major depressive disorder. Items are scored on a 4-point scale from "0" = not at all to "3" = nearly every day. Total scores range from 0 to 27 with higher scores reflecting increased depression severity. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively.

  Baseline, 2 weeks, 4 weeks, 6 weeks (post-intervention), 12 weeks (follow-up)

Secondary Outcomes (8)

• General Anxiety Disorder Scale (GAD-7)

  Baseline, 2 weeks, 4 weeks, 6 weeks (post-intervention), 12 weeks (follow-up)

• Snaith-Hamilton Pleasure Scale (SHAPS)

  Baseline, 6 weeks (post-intervention), 12 weeks (follow-up)

• Perceived deficits questionnaire-5-item (PDQ-5)

  Baseline, 6 weeks (post-intervention), 12 weeks (follow-up)

• The Medical Outcomes Study (MOS) 12-item Short-Form Health Survey (SF-12)

  Baseline, 6 weeks (post-intervention), 12 weeks (follow-up)

• Work and Social Adjustment Scale (WSAS)

  Baseline, 6 weeks (post-intervention), 12 weeks (follow-up)

Other Outcomes (1)

• Weight

  Baseline, 6 weeks (post-intervention), 12 weeks (follow-up)

Study Arms (2)

Ketogenic Diet (KD)

EXPERIMENTAL

Participants allocated to this condition will receive 6-weeks of home-delivered pre-prepared ketogenic diet (KD) meals (3 meals/day, snacks) from a vetted ketogenic diet food supplier. The 6-week intervention includes a weekly 30-minute dietary counselling call with a registered dietitian to support following a ketogenic diet. Participants receive educational materials with information about foods that are compatible with the diet, common symptoms and how to manage them, and strategies to help maintain the diet during and after the 6-week intervention period.

Behavioral: Ketogenic Diet

Phytonutrient Diet (PD)

PLACEBO COMPARATOR

Participants in the control group will receive weekly 30-minute dietary counselling with a registered dietitian and be asked to increase vegetable consumption and reduce saturated fat intake as part of a phytonutrient diet (PD). Participants will receive food vouchers every 2-weeks to help purchase food items or replacements that support high vegetable, low saturated fat intake. This aims to be a plausible placebo dietary treatment for depression. There is no clear evidence that these manipulations will change depression severity. The dietitian will provide materials to explain the diet and suggest foods by colour with supporting recipe suggestions.

Behavioral: Phytonutrient Diet

Interventions

Ketogenic Diet BEHAVIORAL

A Ketogenic Diet (KD) is a high-fat and very low-carbohydrate intake. Participants will follow a modified KD (estimated 20-50g carbohydrates/day based on a 2000 kcal diet) without energy restriction. Participants will test for ketosis in their morning urine at least twice a week to monitor adherence. To support adherence in people with depression, delivered pre-prepared KD meals (3 meals per day) and additional ketogenic snacks will be sent to participants. A registered dietitian will provide weekly 30-minute nutritional counselling sessions. The dietitian will schedule appointments and assess the participants' experience with adhering to the KD diet, troubleshoot as required, give guidance on how to prevent or overcome side effects of KD diets, and keep record of participants' ketosis level and suicide risk.

Also known as: Keto Diet

Ketogenic Diet (KD)

Phytonutrient Diet BEHAVIORAL

Participants in the control group will receive the same degree of dietetic input and be told that their diet is a modified fat and phytonutrient diet. The photo diet aims to increase vegetable consumption, reduce saturated fat intake and increase poly- and mono-unsaturated fat intake. Participants in the control group will receive food vouchers (£20 every two weeks) to help purchase these items. This aims to be a plausible placebo dietary treatment for depression. There is no clear evidence that these manipulations will change depression severity. The dietitian will create written materials to explain the diet and suggest foods by colour with supporting recipe suggestions.

Also known as: Phyto Diet

Phytonutrient Diet (PD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years
• Have been diagnosed with depression
• Currently on an antidepressant medication for a period of 4-weeks or longer
• Have tried 2 or more antidepressant treatment trials of adequate dose and duration within the current depressive episode to which they did not fully respond. An adequate treatment trial is defined as at least 4 weeks of a medication at a minimum National Institute for Health and Care Excellence (NICE) approved dose
• With a Patient Health Questionnaire-9 (PHQ-9) total score greater than or equal to 15 at baseline
• Able to understand and be willing to adhere to the demands of the study
• Provision of written informed consent
• Have access to a tablet/computer for online assessments, follow-ups with the registered dietitian, and able to attend appointments for assessments and treatment and adhere to study procedures
• Have both a fridge and a freezer at home
• Complete all baseline assessments

You may not qualify if:

• Currently following a low carbohydrate or ketogenic diet
• Currently following a vegan or vegetarian diet as these diets are more challenging to accommodate in a Ketogenic Diet and adding vegetables in the control group is unlikely to be seen as helpful.
• Currently receiving, or have received, in-patient psychiatric treatment or electroconvulsive therapy (electric shock to the brain under brief general anaesthetic) within the past year, or scheduled to receive such treatment during the study
• Currently using St John's wort or other remedies for depression that were bought without a doctor's prescription
• Currently have suicidal ideation with intent\* or attempted suicide within the past two months
• Ever had an eating disorder, bipolar disorder, schizophrenia, or psychosis
• Have substance use or alcohol dependence
• Have epilepsy
• Have serious food allergies (experiencing food hypersensitivity that leads to anaphylaxis or other severe symptoms, which may require hospitalisation or are life-threatening) or otherwise require a special diet that cannot be accommodated within a KD such as phenylketonuria or lactose intolerance
• Treated with insulin, sulfonylureas, Glucagon-like peptide-1 (GLP-1) agonists, or Sodium-glucose co-transporter-2 (SGLT2) inhibitors
• Women who are pregnant, planning pregnancy in the next three months, or breastfeeding
• Have a body mass index (BMI) of \<18.5 kg/m2
• Have unstable or severe medical conditions (e.g., cancer, cardiovascular, renal, lung, psychiatric, or bleeding disorders, diabetes, etc.), currently receiving cancer treatment except hormonal treatment for breast cancer or non-melanoma skin cancer treatment
• Have gallstones, renal tubular acidosis, kidney stones, small bowel malabsorption or a history of pancreatitis
• Have scheduled a major surgery in the next 3 months

Sponsors & Collaborators

• University of Oxford: lead
• University of Sheffield: collaborator
• McPin Foundation: collaborator

Study Sites (1)

University of Oxford

Oxford, OX2 6GG, United Kingdom

Location

Related Publications (40)

• Ali S, Rhodes L, Moreea O, McMillan D, Gilbody S, Leach C, Lucock M, Lutz W, Delgadillo J. How durable is the effect of low intensity CBT for depression and anxiety? Remission and relapse in a longitudinal cohort study. Behav Res Ther. 2017 Jul;94:1-8. doi: 10.1016/j.brat.2017.04.006. Epub 2017 Apr 18.

  PMID: 28437680 BACKGROUND

• Chesney E, Goodwin GM, Fazel S. Risks of all-cause and suicide mortality in mental disorders: a meta-review. World Psychiatry. 2014 Jun;13(2):153-60. doi: 10.1002/wps.20128.

  PMID: 24890068 BACKGROUND

• Johnson CF, Macdonald HJ, Atkinson P, Buchanan AI, Downes N, Dougall N. Reviewing long-term antidepressants can reduce drug burden: a prospective observational cohort study. Br J Gen Pract. 2012 Nov;62(604):e773-9. doi: 10.3399/bjgp12X658304.

  PMID: 23211181 BACKGROUND

• Martin K, Jackson CF, Levy RG, Cooper PN. Ketogenic diet and other dietary treatments for epilepsy. Cochrane Database Syst Rev. 2016 Feb 9;2:CD001903. doi: 10.1002/14651858.CD001903.pub3.

  PMID: 26859528 BACKGROUND

• Garcia-Rodriguez D, Gimenez-Cassina A. Ketone Bodies in the Brain Beyond Fuel Metabolism: From Excitability to Gene Expression and Cell Signaling. Front Mol Neurosci. 2021 Aug 27;14:732120. doi: 10.3389/fnmol.2021.732120. eCollection 2021.

  PMID: 34512261 BACKGROUND

• Zarnowski T, Choragiewicz T, Tulidowicz-Bielak M, Thaler S, Rejdak R, Zarnowski I, Turski WA, Gasior M. Ketogenic diet increases concentrations of kynurenic acid in discrete brain structures of young and adult rats. J Neural Transm (Vienna). 2012 Jun;119(6):679-84. doi: 10.1007/s00702-011-0750-2. Epub 2011 Dec 27.

  PMID: 22200857 BACKGROUND

• Page CE, Coutellier L. Prefrontal excitatory/inhibitory balance in stress and emotional disorders: Evidence for over-inhibition. Neurosci Biobehav Rev. 2019 Oct;105:39-51. doi: 10.1016/j.neubiorev.2019.07.024. Epub 2019 Aug 1.

  PMID: 31377218 BACKGROUND

• Duman RS, Sanacora G, Krystal JH. Altered Connectivity in Depression: GABA and Glutamate Neurotransmitter Deficits and Reversal by Novel Treatments. Neuron. 2019 Apr 3;102(1):75-90. doi: 10.1016/j.neuron.2019.03.013.

  PMID: 30946828 BACKGROUND

• Yudkoff M, Daikhin Y, Nissim I, Horyn O, Lazarow A, Luhovyy B, Wehrli S, Nissim I. Response of brain amino acid metabolism to ketosis. Neurochem Int. 2005 Jul;47(1-2):119-28. doi: 10.1016/j.neuint.2005.04.014.

  PMID: 15888376 BACKGROUND

• Duking T, Spieth L, Berghoff SA, Piepkorn L, Schmidke AM, Mitkovski M, Kannaiyan N, Hosang L, Scholz P, Shaib AH, Schneider LV, Hesse D, Ruhwedel T, Sun T, Linhoff L, Trevisiol A, Kohler S, Pastor AM, Misgeld T, Sereda M, Hassouna I, Rossner MJ, Odoardi F, Ischebeck T, de Hoz L, Hirrlinger J, Jahn O, Saher G. Ketogenic diet uncovers differential metabolic plasticity of brain cells. Sci Adv. 2022 Sep 16;8(37):eabo7639. doi: 10.1126/sciadv.abo7639. Epub 2022 Sep 16.

  PMID: 36112685 BACKGROUND

• Guan YF, Huang GB, Xu MD, Gao F, Lin S, Huang J, Wang J, Li YQ, Wu CH, Yao S, Wang Y, Zhang YL, Teoh JP, Xuan A, Sun XD. Anti-depression effects of ketogenic diet are mediated via the restoration of microglial activation and neuronal excitability in the lateral habenula. Brain Behav Immun. 2020 Aug;88:748-762. doi: 10.1016/j.bbi.2020.05.032. Epub 2020 May 12.

  PMID: 32413556 BACKGROUND

• Brietzke E, Mansur RB, Subramaniapillai M, Balanza-Martinez V, Vinberg M, Gonzalez-Pinto A, Rosenblat JD, Ho R, McIntyre RS. Ketogenic diet as a metabolic therapy for mood disorders: Evidence and developments. Neurosci Biobehav Rev. 2018 Nov;94:11-16. doi: 10.1016/j.neubiorev.2018.07.020. Epub 2018 Jul 31.

  PMID: 30075165 BACKGROUND

• Fattal O, Budur K, Vaughan AJ, Franco K. Review of the literature on major mental disorders in adult patients with mitochondrial diseases. Psychosomatics. 2006 Jan-Feb;47(1):1-7. doi: 10.1176/appi.psy.47.1.1.

  PMID: 16384802 BACKGROUND

• Yarar-Fisher C, Li J, Womack ED, Alharbi A, Seira O, Kolehmainen KL, Plunet WT, Alaeiilkhchi N, Tetzlaff W. Ketogenic regimens for acute neurotraumatic events. Curr Opin Biotechnol. 2021 Aug;70:68-74. doi: 10.1016/j.copbio.2020.12.009. Epub 2021 Jan 11.

  PMID: 33445134 BACKGROUND

• Puchowicz MA, Xu K, Sun X, Ivy A, Emancipator D, LaManna JC. Diet-induced ketosis increases capillary density without altered blood flow in rat brain. Am J Physiol Endocrinol Metab. 2007 Jun;292(6):E1607-15. doi: 10.1152/ajpendo.00512.2006. Epub 2007 Feb 6.

  PMID: 17284577 BACKGROUND

• Jarrett SG, Milder JB, Liang LP, Patel M. The ketogenic diet increases mitochondrial glutathione levels. J Neurochem. 2008 Aug;106(3):1044-51. doi: 10.1111/j.1471-4159.2008.05460.x. Epub 2008 May 5.

  PMID: 18466343 BACKGROUND

• Villa RF, Ferrari F, Bagini L, Gorini A, Brunello N, Tascedda F. Mitochondrial energy metabolism of rat hippocampus after treatment with the antidepressants desipramine and fluoxetine. Neuropharmacology. 2017 Jul 15;121:30-38. doi: 10.1016/j.neuropharm.2017.04.025. Epub 2017 Apr 18.

  PMID: 28431972 BACKGROUND

• Guarnotta V, Emanuele F, Amodei R, Giordano C. Very Low-Calorie Ketogenic Diet: A Potential Application in the Treatment of Hypercortisolism Comorbidities. Nutrients. 2022 Jun 9;14(12):2388. doi: 10.3390/nu14122388.

  PMID: 35745118 BACKGROUND

• Ebbeling CB, Feldman HA, Klein GL, Wong JMW, Bielak L, Steltz SK, Luoto PK, Wolfe RR, Wong WW, Ludwig DS. Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial. BMJ. 2018 Nov 14;363:k4583. doi: 10.1136/bmj.k4583.

  PMID: 30429127 BACKGROUND

• Karkkainen O, Farokhnia M, Klavus A, Auriola S, Lehtonen M, Deschaine SL, Piacentino D, Abshire KM, Jackson SN, Leggio L. Effect of intravenous ghrelin administration, combined with alcohol, on circulating metabolome in heavy drinking individuals with alcohol use disorder. Alcohol Clin Exp Res. 2021 Nov;45(11):2207-2216. doi: 10.1111/acer.14719. Epub 2021 Sep 30.

  PMID: 34590334 BACKGROUND

• Attaye I, van Oppenraaij S, Warmbrunn MV, Nieuwdorp M. The Role of the Gut Microbiota on the Beneficial Effects of Ketogenic Diets. Nutrients. 2021 Dec 31;14(1):191. doi: 10.3390/nu14010191.

  PMID: 35011071 BACKGROUND

• Bough KJ, Wetherington J, Hassel B, Pare JF, Gawryluk JW, Greene JG, Shaw R, Smith Y, Geiger JD, Dingledine RJ. Mitochondrial biogenesis in the anticonvulsant mechanism of the ketogenic diet. Ann Neurol. 2006 Aug;60(2):223-35. doi: 10.1002/ana.20899.

  PMID: 16807920 BACKGROUND

• Hallbook T, Ji S, Maudsley S, Martin B. The effects of the ketogenic diet on behavior and cognition. Epilepsy Res. 2012 Jul;100(3):304-9. doi: 10.1016/j.eplepsyres.2011.04.017. Epub 2011 Aug 27.

  PMID: 21872440 BACKGROUND

• van Berkel AA, IJff DM, Verkuyl JM. Cognitive benefits of the ketogenic diet in patients with epilepsy: A systematic overview. Epilepsy Behav. 2018 Oct;87:69-77. doi: 10.1016/j.yebeh.2018.06.004. Epub 2018 Aug 31.

  PMID: 30173019 BACKGROUND

• Dietch DM, Kerr-Gaffney J, Hockey M, Marx W, Ruusunen A, Young AH, Berk M, Mondelli V. Efficacy of low carbohydrate and ketogenic diets in treating mood and anxiety disorders: systematic review and implications for clinical practice. BJPsych Open. 2023 Apr 17;9(3):e70. doi: 10.1192/bjo.2023.36.

  PMID: 37066662 BACKGROUND

• Cuijpers P, Karyotaki E, Weitz E, Andersson G, Hollon SD, van Straten A. The effects of psychotherapies for major depression in adults on remission, recovery and improvement: a meta-analysis. J Affect Disord. 2014 Apr;159:118-26. doi: 10.1016/j.jad.2014.02.026. Epub 2014 Feb 24.

  PMID: 24679399 BACKGROUND

• Khan A, Brown WA. Antidepressants versus placebo in major depression: an overview. World Psychiatry. 2015 Oct;14(3):294-300. doi: 10.1002/wps.20241.

  PMID: 26407778 BACKGROUND

• Cummergen K, Hannah L, Jopling L, Cameron R, Walsh C, Perez J. What outcomes matter to service users who experience persistent depression: A mixed-method narrative review and synthesis. Journal of Affective Disorders Reports 2022; 10: 100431.

  BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Snaith RP, Hamilton M, Morley S, Humayan A, Hargreaves D, Trigwell P. A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995 Jul;167(1):99-103. doi: 10.1192/bjp.167.1.99.

  PMID: 7551619 BACKGROUND

• Lam RW, Lamy FX, Danchenko N, Yarlas A, White MK, Rive B, Saragoussi D. Psychometric validation of the Perceived Deficits Questionnaire-Depression (PDQ-D) instrument in US and UK respondents with major depressive disorder. Neuropsychiatr Dis Treat. 2018 Oct 29;14:2861-2877. doi: 10.2147/NDT.S175188. eCollection 2018.

  PMID: 30464471 BACKGROUND

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.

  PMID: 11983645 BACKGROUND

• Walsh AEL, Browning M, Drevets WC, Furey M, Harmer CJ. Dissociable temporal effects of bupropion on behavioural measures of emotional and reward processing in depression. Philos Trans R Soc Lond B Biol Sci. 2018 Mar 19;373(1742):20170030. doi: 10.1098/rstb.2017.0030.

  PMID: 29352029 BACKGROUND

• Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.

  PMID: 15550799 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

  PMID: 20332509 BACKGROUND

• Miletic S, Boag RJ, Trutti AC, Stevenson N, Forstmann BU, Heathcote A. A new model of decision processing in instrumental learning tasks. Elife. 2021 Jan 27;10:e63055. doi: 10.7554/eLife.63055.

  PMID: 33501916 BACKGROUND

• Mordor Intelligence LLC. Global Ketogenic Diet Food Market - Growth, Trends and Forecast (2019 - 2024). 2019. https://www.reportlinker.com/p05790924/Global-Ketogenic-Diet-Food-Market-Growth-Trends-and-Forecast.html#:~:text=The%20global%20ketogenic%20diet%20food,and%20aiding%20in%20weight%2Dloss.

  BACKGROUND

• Gao M, Kirk M, Knight H, Lash E, Michalopoulou M, Guess N, Stevens R, Browning M, Weich S, Burnet PWJ, Jebb SA, Aveyard P. A Ketogenic Diet for Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Feb 4:e254431. doi: 10.1001/jamapsychiatry.2025.4431. Online ahead of print.

  PMID: 41637092 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression; Mental Disorders; Depressive Disorder; Ketosis

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Mood Disorders; Behavioral Symptoms; Behavior; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Min Gao, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Megan Kirk Chang, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Paul Aveyard, PhD, FRCGP

  University of Oxford

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: February 22, 2024
• Primary Completion: June 15, 2024
• Study Completion: September 30, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after publication in a peer-reviewed journal for a period of up to 12-months.
• Access Criteria: Please contact the primary investigators listed on this trial registration for access.

Locations

GB (1)