NCT06221852Recruiting
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.
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Jan 2024
- Start date
- 12 Mar 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Mclean Hospital
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT06221852
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 12 Mar 2024 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant treatment with Propofol
Other illness
- Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)
- Current DSM-5 substance use disorder
- 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
Other
- Unable to sign informed consent
- Contraindication to magnetic resonance (MR) scan (including claustrophobia)
- 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)
- Familial hypercholesterolemia
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.