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

A Randomized Controlled Trial of a Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 25 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Additionally, those conditions share epidemiological traits, including significant cardiovascular, metabolic, infectious, and respiratory comorbidities, resulting in reduced life expectancy of up to 25 years (Xie et al., 2023)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

CA