RECRUITING

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-12
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06221852

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 18 and 45.
  2. * Ability to adhere to study diets.
  3. * 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.
  4. * Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening
  5. * Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study.
  1. * Unable to sign informed consent
  2. * Contraindication to magnetic resonance (MR) scan (including claustrophobia)
  3. * Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)
  4. * Current DSM-5 substance use disorder
  5. * Currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception
  6. * Have a body weight of over 350 lbs or a body mass index (BMI) \<20
  7. * Score above 15 on the Young Mania Rating Scale (YMRS)
  8. * History of significant head injury
  9. * Current cancer diagnosis
  10. * Current diagnosis of type 1 or type 2 Diabetes Mellitus
  11. * History of gastric bypass surgery or any weight loss surgery
  12. * Concomitant treatment with Propofol
  13. * Familial hypercholesterolemia

Contacts and Locations

Study Contact

Jacey Anderson, B.A.
CONTACT
617-855-3988
janderson75@mclean.harvard.edu
Virginie-Anne Chouinard, MD
CONTACT
vchouinard@mclean.harvard.edu

Principal Investigator

Virginie-Anne Chouinard, MD
PRINCIPAL_INVESTIGATOR
Mclean Hospital

Study Locations (Sites)

McLean Hospital
Belmont, Massachusetts, 02478
United States

Collaborators and Investigators

Sponsor: Mclean Hospital

  • Virginie-Anne Chouinard, MD, PRINCIPAL_INVESTIGATOR, Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-12
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2024-03-12
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • First episode psychosis
  • Ketogenic Diet
  • Keto
  • Brain energy metabolism
  • Insulin resistance
  • Schizoaffective Disorder
  • Bipolar Disorder
  • Magnetic resonance spectroscopy (MRS)
  • Redox
  • Creatine kinase

Additional Relevant MeSH Terms

  • Bipolar I Disorder
  • Psychosis
  • Schizoaffective Disorder