Note: This study is currently only recruiting patients in the hospital.
If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.
Have you experienced bipolar disorder or psychosis? Seeking participants for a dietary study.
Enrollment for this study is expected to close on Friday, February 20, 2026
Overview
What we are studying
We are studying whether your diet can have an effect on energy pathways in the brain and can improve cognition, mood, and psychosis. There is evidence for diet modification being beneficial in other conditions such as epilepsy. In this study, we will compare the ketogenic diet and a standard diet and their effects on brain energy.
Why it is important
This resesarch is important because millions of people around the world suffer from mood and psychotic disorders and there is an urgent need for new and improved treatments. Improving energy metabolism in the brain may be beneficial for treating symptoms. Finding a dietary intervention that works may help advance current treatments for mood and psychotic disorders and help people in their recovery and achieving their goals.
What we hope to accomplish
We are going to study whether the ketogenic diet or a standard diet impact energy metabolism in the brain and psychiatric symptoms. We will do this by having participants follow an assigned diet for 12 - 24 weeks with dietician support and provided meals (at no cost to the participant).
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Principal Investigator
Contact
Click I Am Interested "I Am Interested" "I Am Interested" to get started. If you have questions, contact:
Jacey Anderson
Who can participate
People ages 18-45 who have experienced their first episode of psychosis in the past 7 years. Diagnoses such as bipolar I disorder or schizoaffective disorder will be included.
Who cannot participate
At this time, participants are required to be in Massachusetts for the duration of the study.
What you may be asked to do
After informed consent, participants will have a psychiatric interview over zoom to confirm eligibility. After that, they weill come to McLean Hospital for an in-person screening visit involving a blood draw, measurement of height, weight, and vital signs, and questions about current symptoms to ensure it is safe to start a new diet. If eligible, participants will have a baseline visit where they will: answer questions about their medical and psychiatric history; have a physical exam; provide a urine sample for drug and pregnancy screening; do 2 MRI scans; have blood drawn; do a cognitive assessment; be assigned to either the ketogenic diet or the standard diet; have a consultation with a registered dietician. After the baseline visit, participants will have up to 3 meals per day delivered to their homes for 12 weeks or have the option to cook their own meals. Study staff will provide them with a device called a Keto Mojo that is used to measure blood glucose and ketone levels each day with a finger prick. During the 12-week period, participants will have weekly virtual visits with study staff and dieticians. At weeks 3, 6, and 9, the weekly visit will be in person to conduct assessments such as psychiatric questionnaires, cognitive testing, blood draw, and an MRI. At week 12, participants have their final in-person visit at McLean that will be very similar to the baseline visit. Participants have the opportunity of signing up for the optional open label phase of the study, which lasts an additional 12 weeks. This phase will be the same as the first phase, except all participants will adhere to the ketogenic diet. This means that everyone enrolled in the study will get a chance to try the ketogenic diet. Visits during this second phase will include an in-person visit at 18 weeks and 24 weeks, along with weekly or biweekly virtual visits.
Project activities may include:
- Survey
- Blood draw
- Office visit
- MRI scan
- Biosample (e.g., saliva, urine, or stool)
Estimated Time Commitment
27 hours over 12 weeks
What You May Get
Your participation will be compensated up to $2,415 for completing both phases of the study. You will also receive up to 3 free meals per day for 12 weeks, as well as weekly nutrition coaching from a registered dietician. You will also receive a meal voucher worth $15 at our cafeteria for each in-person visit.
Location
McLean Hospital
115 Mill St, Belmont, MA
Travel
- Accessible by public transportation
- Parking available
- Local travel reimbursed
Travel and Parking Details
Accessible via the 73 bus from Harvard. Free parking on-site. Transportation reimbursed with receipt.
Additional Information
Funding Source
- Foundation