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

Inclusion Criteria:

   1. Male or female, 18 to 75 years of age.

   2. Able to provide informed consent.

   3. Meet DSM V criteria for diagnosis with Bipolar Disorder (BPD), any subtype, for > 1
   year and clinically stable (with no hospitalization for past 3 months)

   4. Participants may currently be on a stable and adequate dose of SSRI antidepressant
   therapy or other psychiatric medications. Concurrent hypnotic therapy (e.g., with
   zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been
   stable for at least 4 weeks prior to screening and if it is expected to remain stable.
   Participants may choose to not be on antidepressant therapy for the study duration, or
   to be switched from other classes to a medication from the SSRI class.

   5. currently taking SSRI or psychotropic medication and gained at least 5% weight since
   starting medication or have a BMI greater than or equal to 26 kg/m2 or presence of at
   least one metabolic abnormality (hypertriglyceridemia, insulin resistance,
   dyslipidemia, impaired glucose tolerance)

   6. In good general health, as ascertained by medical history.

   7. If female, a status of non-childbearing potential or use of an acceptable form of
   birth control. The form of birth control will be documented at screening and baseline.

   8. willing to consent to all study procedures and attend follow-up appointments and
   motivated to follow dietary program.

   9. Sufficient control over their food intake to adhere to study diets.

10. willingness to regularly monitor blood pressure, glucose, dietary intake, and body
   weight over 6-week trial

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)