Bipolar Disorder Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 50 years old
• You are willing to switch to a high-fat, low-carbohydrate (ketogenic-style) diet
• You have been diagnosed with Bipolar I disorder, Bipolar II disorder, or schizoaffective disorder (bipolar type), confirmed through a structured medical interview
• You have at least mild depression symptoms and have been on a stable mood medication (such as lithium, valproate, or an antipsychotic) for at least 2 weeks
• Your urine drug test comes back negative, except for any medications you have been prescribed (such as certain anti-anxiety medicines)
• You have a negative pregnancy test
• If you are sexually active, you are using a reliable form of birth control
• Any other health conditions you have (such as high blood pressure or type 2 diabetes) are currently stable and well-managed

Who may not be able to join:

• You do not have access to a smartphone or the internet (unless the study provides one for you)
• You are unable or unwilling to give written consent, or you cannot pass a basic quiz (scoring at least 80%) about what the study involves
• You have a confirmed diagnosis of schizophrenia or are currently experiencing psychotic symptoms
• You have a personality disorder that is considered your main psychiatric diagnosis, based on a review by the study psychiatrist
• You are currently experiencing a mix of depression and high-energy (hypomanic) symptoms at the same time
• You are currently having thoughts of suicide with any intention or plan
• You currently have a drug or alcohol use disorder (not including nicotine); you may qualify if you have been fully in recovery for 3 or more months
• You test positive for cannabis use and are found to have a cannabis use disorder (though you may still be considered if your cannabis use score is below a certain threshold — confirm with trial site)
• You are currently receiving electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or deep brain stimulation as a treatment
• You are currently held in a psychiatric facility against your will
• Your body is already in a state of ketosis, or you are taking a medication that causes a related condition called acidosis (such as topiramate or acetazolamide)
• Your BMI is below 18.5 (considered underweight), or your "bad" cholesterol (LDL) level is above 190
• You have any active or unstable medical condition that the study doctor considers too risky, such as a serious ongoing infection
• You have had pancreatitis (inflammation of the pancreas) or a history of it linked to high fat levels in the blood
• You have Type 1 diabetes
• You are taking a type of diabetes medication called an SGLT2 inhibitor
• You have a rare inherited condition affecting how your body processes fats (such as Pyruvate carboxylase deficiency or Porphyria) — these are usually diagnosed in infancy (confirm with trial site)
• You have a condition called primary carnitine deficiency
• You have serious kidney disease or are on dialysis
• You have a severe vitamin D deficiency based on a blood test
• You have been diagnosed with low bone density (osteopenia) or have had a fragility fracture (a bone break from a minor injury)
• You have significantly abnormal results on routine lab tests
• You are planning to have a non-emergency surgery within the next 18 weeks
• A close male relative (father or brother) had a heart attack or stroke before age 55, or a close female relative (mother or sister) had one before age 65
• You have a personal or family history of a condition causing very high cholesterol, or your cholesterol or triglyceride levels are above certain thresholds
• You have a history of heart disease, blocked arteries in the heart, or significant calcium deposits in your coronary arteries
• You have had a stroke caused by a blocked blood vessel, or an ultrasound has found plaque buildup in the arteries in your neck
• You have a history of blocked arteries in your legs or elsewhere in your body
• You have a history of or currently have serious breathing problems where your blood oxygen levels are dangerously low
• You have liver failure or serious ongoing liver disease, shown by very abnormal liver blood test results

Important: Always verify eligibility with the trial site directly before applying.