Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness

Exclusion Criteria

• •1. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
• •2. Female that is pregnant or breastfeeding.
• •3. Female with a positive pregnancy test at participation.
• •4. comorbidity of developmental delay or Cognitive impairment (as noted by previous diagnoses-including dementia).
• •5. Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence, at screening or within six months prior to screening.
• •6. History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
• •7. Current (or chronic) use of opiates.
• •8. in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary program.
• •9. Considered at significant risk for suicide during the course of the study.
• •10. any one who has been hospitalized or taken clozapine at doses above 550mg over the past 3 months
• •11. Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
• •12. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
• •13. Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
• •14. inability to complete baseline measurements
• •15. severe renal or hepatic insufficiency
• •16. cardiovascular dysfunction, including diagnosis of:
• •1. Congestive heart failure
• •2. Angina
• •3. Arrhythmias
• •4. Cardiomyopathy
• •5. Valvular heart disease
• •6. History of cardiovascular disease or cardiac event.
• •17. any other medical condition that may make either diet dangerous as determined by the study medical team (e.g. anorexia nervosa)