Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Description

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.

Conditions

Bipolar I Disorder, Psychosis, Schizoaffective Disorder

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Study Overview

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Study Details

Study overview

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.

A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Condition
Bipolar I Disorder
Intervention / Treatment

-

Contacts and Locations

Belmont

McLean Hospital, Belmont, Massachusetts, United States, 02478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study.
  • * 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
  • * Currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception
  • * Have a body weight of over 350 lbs or a body mass index (BMI) \<20
  • * Score above 15 on the Young Mania Rating Scale (YMRS)
  • * History of significant head injury
  • * Current cancer diagnosis
  • * Current diagnosis of type 1 or type 2 Diabetes Mellitus
  • * History of gastric bypass surgery or any weight loss surgery
  • * Concomitant treatment with Propofol
  • * Familial hypercholesterolemia

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mclean Hospital,

Virginie-Anne Chouinard, MD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

2027-12-30