Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMclean Hospital
About this trial
This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.
Eligibility criteria
Qualifiers
Between the ages of 18 and 45.
Ability to adhere to study diets.
Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years.
Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening
Disqualifiers
Unable to sign informed consent
Contraindication to magnetic resonance (MR) scan (including claustrophobia)
Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)
Current DSM-5 substance use disorder
Trial design
Treatments tested in this trial
- Ketogenic diet
- Dietary Guidelines for Americans
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mclean Hospital
Lead sponsor
Baszucki Family Foundation
Collaborator
Source ClinicalTrials.gov