Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 45 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Investigators will measure the effects of nutritional ketosis on brain redox and energy metabolism and other neurometabolic markers using magnetic resonance spectroscopy."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a ketogenic diet, which is high in fat and very low in carbs, along with usual treatment. It looks at how the brain uses energy and at mental health symptoms. It is for adults ages 18–45 with bipolar I disorder or schizoaffective disorder whose illness began within the past 7 years.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–45 years old.
- You can follow the study diets.
- You have a diagnosis of bipolar I disorder or schizoaffective disorder, which affects mood and thinking. Your illness began within the past 7 years.
- Your mental health condition is stable, and your mental health medicines have not changed in the 2 weeks before screening.
- You are not expected to need any new mental health medicines during the 12-week study.
Who can't join
- You cannot sign a form agreeing to join the study after learning about it.
- You cannot safely have a magnetic resonance (MR) scan, including because of fear of enclosed spaces, or you have had a serious head injury.
- You have cancer or an unstable medical illness, such as a heart, liver, kidney, lung, hormone, nerve, or blood disease.
- You currently have a substance use disorder, or your score is above 15 on the Young Mania Rating Scale, a test of unusually high mood and energy.
- You are pregnant or breastfeeding, or you could become pregnant and are not using medically accepted birth control.
- You weigh more than 350 pounds, have a body mass index (BMI, a measure based on height and weight) below 20, or have had weight-loss surgery.
- You have type 1 or type 2 diabetes, or familial hypercholesterolemia, an inherited condition that causes high cholesterol.
- You are receiving propofol, a medicine used for sedation or anesthesia.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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. Exclusion Criteria: * 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
Study sites (1)
MA
- McLean Hospital · Belmont, MA 02478Kaitlin Shannon, B.A. · Study contact · kshannon6@mgb.orgVirginie-Anne Chouinard, MD · Principal investigatorMore trials in Belmont