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New treatment option for Bipolar Disorder (BD)
Official title Child Bipolar Network Ketogenic Diet Approach to Bipolar Disorder in Adolescents
ClinicalTrials.gov ID: NCT06920940
What this study is testing
- What it's testing
- The present study is an open trial of ketogenic diets for adolescents and young adults (ages 12-21 yrs) in the depressive or mixed phases of bipolar disorder (BD). The investigators aim to determine whether combining standard of care pharmacological treatment for bipolar spectrum disorders with a 16-week ketogenic diet is well-tolerated and associated with improvements in depression, inflammatory and metabolic indicators, and executive functioning over the study period.
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 21
You may be able to join if
- Youth must be ages 12 to 21 years old and speak English
- Youth must be appropriate for outpatient treatment (i.e., not a danger to self or others; not acutely psychotic, suicidal or manic; not in need of...
- Youth must have a current BSD (bipolar I, II per DSM-5 criteria (Association, 2013) or other specified BSD by the University of Pittsburgh diagnostic...
- Active symptoms: In the 2 weeks prior to study intake, participants must have had weekly depression Psychiatric Status Ratings (PSRs) of 3 (moderate)...
- Participants must continue to meet the study's active symptom criteria when beginning the phase II keto "ramp-up" phase: a depression PSR rating of 3...
You likely can't join if
- The youth must not have any of the following needs or conditions for which the keto diet may be contraindicated:
- pregnancy or breastfeeding
- underweight (BMI below 18.5) or wasting syndrome (e.g., anorexia cachexia)
- current or history of anorexia nervosa
- current disordered eating (bulimia or binge eating disorder)
- autism spectrum disorder diagnosis level 2 or greater (more than mild)
See the full eligibility criteria
- Youth must be ages 12 to 21 years old and speak English
- Youth must be appropriate for outpatient treatment (i.e., not a danger to self or others; not acutely psychotic, suicidal or manic; not in need of partial or full hospitalization)
- Youth must have a current BSD (bipolar I, II per DSM-5 criteria (Association, 2013) or other specified BSD by the University of Pittsburgh diagnostic criteria (Birmaher et al., 2006). The Pittsburgh other specified BSD...
- Active symptoms: In the 2 weeks prior to study intake, participants must have had weekly depression Psychiatric Status Ratings (PSRs) of 3 (moderate) or higher (using the 1-6 depression severity scales from the...
- Participants must continue to meet the study's active symptom criteria when beginning the phase II keto "ramp-up" phase: a depression PSR rating of 3 or higher over the prior 2 weeks, and a CDRS-R score covering the...
- Youth/parents must be willing to participate in evaluation and medication management sessions with a study psychiatrist and the study dietitian for assessment of the diet and side effects.
- Youth under 18 years old must have at least one English-speaking parent or other caregiving family member consenting to participate in the study and available for consultation if needed
- Youth and (for minors) all parents/legal guardians with health care decision making rights must express willingness to have the youth be in the study and try the keto therapy, assuming that the youth is eligible. The...
- The youth must not have any of the following needs or conditions for which the keto diet may be contraindicated:
- pregnancy or breastfeeding
- underweight (BMI below 18.5) or wasting syndrome (e.g., anorexia cachexia)
- current or history of anorexia nervosa
- current disordered eating (bulimia or binge eating disorder)
- autism spectrum disorder diagnosis level 2 or greater (more than mild)
- cardiac issues, including history of arrhythmia, or cardiovascular or cerebrovascular disease
- type I and type II diabetes
- history of seizures/epilepsy
- history of stroke or cancer
- unstable respiratory condition
- severe gastroesophageal reflux (GERD; painful/impairing despite prescription medication)
- substance use disorder (with an exception for mild cannabis or nicotine use disorders)
- history of kidney stones/disease
- diseases involving the pancreas, liver, gallbladder or thyroid, including Von Gierke's glycogen storage disease
- Condition with high cholesterol of triglycerides will prompt physician review of eligibility (LDL\>190 or triglycerides\>500)
- genetic metabolic disorders: either porphyria (impacting the body's ability to make hemoglobin) or fatty acid oxidation disorder (FAOD)
- rare conditions of defective ketone production or breakdown (carnitine deficiency, carnitine palmitoyl-transferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation...
- youth must not be taking SGLT-2 inhibitors (e.g., canagliflozin), insulin, or sulfonylureas (to avoid hypogycemia), or Antihypertensive medication (e.g., lisinopril/ACE Angiotensin inhibitors ending in "pril", ARB...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Cincinnati, Ohio, United States
- Pittsburgh, Pennsylvania, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; Cincinnati, Ohio, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.