Bipolar Disorder Trial, Recruiting

Written by an AI model from 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 12 and 21 years old and can speak English
• You are suitable for outpatient care, meaning you are not currently in crisis, not at risk of harming yourself or others, and do not need hospitalization
• You have been diagnosed with a bipolar spectrum disorder (such as Bipolar I, Bipolar II, or a milder form that meets specific research criteria)
• In the two weeks before joining, you have been experiencing moderate or higher levels of depression or mixed mood symptoms, based on standard rating tools used by the study team
• You still meet those same active mood symptom levels when you begin the dietary part of the study
• You and your parent or guardian are willing to attend sessions with a study psychiatrist and a dietitian to monitor your health and how well the diet is working
• If you are under 18, at least one English-speaking parent or family caregiver is willing to be involved in the study
• You and any parent or legal guardian with decision-making rights are willing for you to participate and to try the ketogenic (keto) diet, and the study team believes you and your family are likely to follow the study plan carefully

Who may not be able to join:

• You are pregnant or breastfeeding
• You are underweight (BMI below 18.5) or have significant muscle or body wasting
• You have a current or past diagnosis of anorexia nervosa
• You currently have bulimia or binge eating disorder
• You have been diagnosed with autism spectrum disorder at a moderate or higher level (level 2 or above)
• You have heart problems, including an irregular heartbeat, or a history of heart or blood vessel disease
• You have Type 1 or Type 2 diabetes
• You have a history of seizures or epilepsy
• You have a history of stroke or cancer
• You have an unstable breathing or lung condition
• You have severe acid reflux (GERD) that is still painful or disabling even with prescription medication
• You have a substance use disorder, except for mild cannabis or nicotine use (confirm with trial site)
• You have a history of kidney stones or kidney disease
• You have a condition affecting the pancreas, liver, gallbladder, or thyroid, including a specific glycogen storage disease called Von Gierke's disease
• You have very high cholesterol (LDL above 190) or very high triglycerides (above 500) — a doctor will review whether you are still eligible
• You have a genetic disorder called porphyria or a fatty acid oxidation disorder (a condition where your body cannot properly break down fats for energy)
• You have certain rare inherited conditions that affect how your body produces or breaks down ketones, such as carnitine deficiency or several other related disorders (confirm with trial site for the full list)
• You are currently taking certain medications, including SGLT-2 inhibitors (such as canagliflozin), insulin, sulfonylureas, or certain blood pressure medications such as ACE inhibitors (ending in "-pril"), ARBs, spironolactone, or thiazide diuretics

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