Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling

Launched by STANFORD UNIVERSITY · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a ketogenic diet, which is a low-carb and high-fat diet, might help improve the quality of life for people with serious mental health conditions like schizophrenia, bipolar disorder, and major depressive disorder. The researchers want to see if this type of diet can make a difference for those who are stable in their condition and have not been hospitalized for the past three months.

To be eligible for the study, participants must be diagnosed with one of these mental health disorders and meet certain criteria, such as having a moderate to severe level of symptoms. They should also be able to give informed consent and live in the United States. Those who are currently pregnant, nursing, or have other serious health issues may not be able to participate. If someone joins the study, they can expect to follow the ketogenic diet under medical supervision and help researchers understand how it affects their mental health. The trial is not yet recruiting participants, but it aims to gather valuable information about this dietary approach and its potential benefits for mental health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. diagnosed with bipolar disorder (BD), major depressive disorder (MDD), and or schizophrenia
• 1. For individuals diagnosed with bipolar disorder (BD):
• • Meet DSM V criteria for BD (any subtype)
• • Not mild
• • \>40 on BPRS
• • clinically stable (with no hospitalization for past 3 months)
• 2. For individuals diagnosed with major depressive disorder (MDD):
• • Not mild
• • PHQ-9 \> 10
• • clinically stable (with no hospitalization for past 3 months)
• 3. For individuals diagnosed with schizophrenia:
• • Meet DSM V criteria for schizophrenia (any subtype)
• • Not mild
• • \>40 on BPRS
• • clinically stable (with no hospitalization for past 3 months)
• • 2. Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy or other psychiatric medication. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least four weeks prior to screening and if it is expected to remain stable. Participants may be switched from other classes of medication to another medication class by their psychiatrist or primary care doctor, but need to be stable enough to enroll and adhere to study procedures.
• • 3. willing and able to give informed consent for participation in English.
• • 4. live within the United States.
• • --------------------------------------------------------------------------------
• Exclusion Criteria:
• • 1. has started the ketogenic diet or was in ketosis within 3 months of wanting to enroll
• • 2. pregnant or nursing
• • 3. insulin dependent
• • 4. comorbidity of developmental delay
• • 5. in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary programs.
• • 6. any one who has been hospitalized or taken clozapine at doses above 550mg over the past 3 months
• • 7. inability to complete baseline measurements
• • 8. severe renal or hepatic insufficiency
• 9. cardiovascular dysfunction, including diagnosis of:
• • Congestive heart failure
• • Angina
• • Arrhythmias
• • Cardiomyopathy
• • Valvular heart disease
• • 10. active substance abuse with illicit drugs or alcohol and/or current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine or cannabis dependence
• • 11. active suicidal and considered at significant risk for suicide during course of study
• • 12. participation in any clinical trial- within the past month or concurrent to study participation- with an investigational drug/device and/or intervention that may interfere with study participation/evaluation of results
• • 13. mild BPRS at screening or baseline visits
• • 14. history of TBI
• • 15. any other medical condition that may make diet intervention dangerous as determined by the study medical team (e.g. anorexia nervosa) or assessed by study team to have insufficient control over their food intake to adhere to study diets.
• • 16. any medical condition that physicians or the PI believe would interfere with study participation or evaluation of results
• • 17. history of familial hypercholesterolemia