Ketogenic Diet for Bipolar Disorder
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
Must be taking: Atypical antipsychotics, lithium
Must not be taking: Anticoagulants
Disqualifiers: Head injury, Neurological disorder, SUD, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing if a high-fat, low-carb diet can help adults with Bipolar Disorder. The diet increases a substance that might reduce severe mood swings. Researchers will use various methods to study its effects on brain activity and emotions. The diet may have mood-stabilizing properties.
Do I need to stop my current medications to join the trial?
Participants with Bipolar Disorder can continue taking their current medications, such as atypical antipsychotics, lithium, antidepressants, and anxiolytics. The trial does not require stopping these medications.
What data supports the effectiveness of the ketogenic diet as a treatment for bipolar disorder?
The ketogenic diet, known for its success in treating epilepsy, may help stabilize mood in bipolar disorder. Online reports and studies suggest it could be beneficial due to its effects on brain energy and sodium levels, which are important for mood stabilization.
12345Is the ketogenic diet generally safe for humans?
The ketogenic diet has been used for conditions like epilepsy, and while it can be effective, it may cause side effects such as poor growth, high cholesterol levels, and kidney stones, especially in children. However, newer flexible versions of the diet may help reduce these risks.
36789How does the ketogenic diet treatment for bipolar disorder differ from other treatments?
The ketogenic diet is unique for bipolar disorder as it focuses on altering metabolism by reducing carbohydrate intake and increasing fat consumption, which may influence brain energy use and neurotransmitter balance, unlike traditional medications like lithium that target mood stabilization through chemical pathways.
1011121314Eligibility Criteria
Adults aged 18-30 with Bipolar Disorder, either hypomanic or euthymic, who are taking certain BD medications can join. Healthy controls without psychiatric history are also needed. Exclusions include head injury, systemic diseases, substance abuse (except limited cannabis), poor English understanding, and specific medical conditions.Inclusion Criteria
I have bipolar disorder, with more manic than depressive symptoms, and I'm on medication.
I am between 18 and 30 years old.
I have bipolar disorder, am stable on my medication, and my mood scores are low.
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Exclusion Criteria
I am not sex-matched with BD groups and have a psychiatric history.
All participants: Not between 18-30 years of age, History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report), Mini-Mental State Examination score (cognitive state) <24, Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate<85, Visual disturbance: <20/40 Snellen visual acuity, Left/mixed handedness (Annett criteria), History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals, MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy, Unable to understand English, Conditions related to the pancreas, liver, thyroid or gallbladder., Does not have a smartphone with a) iPhone operating system (iOS) version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app
BD hypomanic group: Must be meeting sex proportions: not 50% female, Must be meeting diagnosis proportions: not 50:50% BDI:II (DSM-5), Diagnosis of BD in a depressive, manic, or euthymic episode, Young Mania Rating Scale score(YMRS)10 or lower, Score 8 or higher on Hamilton Rating Scale for Depression(HRSD), Using psychotropic medications other than those allowed in inclusion criteria, Head circumference larger than about 58 cm (size restriction of 7Tesla (7T) scanner)
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline
Baseline assessments including fasting hepatic function panel, fasting glucose, and neuroimaging scans
1 week
1 visit (in-person)
First Dietary Phase
Participants with Bipolar Disorder consume either a ketogenic or non-ketogenic diet, with mood and energy monitoring
8-10 weeks
Continuous monitoring (at-home)
Second Dietary Phase
Participants switch diets (from ketogenic to non-ketogenic or vice versa), with continued mood and energy monitoring
8-10 weeks
Continuous monitoring (at-home)
Follow-up
Participants are monitored for safety and effectiveness after dietary interventions
4 weeks
Participant Groups
The trial is testing the effects of a ketogenic diet versus no diet change or a non-ketogenic diet on brain function and mood in people with Bipolar Disorder. Participants will be monitored to see how their brain activity and emotional state respond to dietary changes.
3Treatment groups
Experimental Treatment
Group I: No dietExperimental Treatment1 Intervention
Participants without Bipolar Disorder will not participate in the diet phases of the study
Group II: 1st phase Non-ketogenic Diet / 2nd phase Ketogenic DietExperimental Treatment2 Interventions
Participants with Bipolar Disorder will consume a non-ketogenic diet for the first phase of the study and then a ketogenic diet for the second phase of the study
Group III: 1st phase Ketogenic Diet / 2nd phase Non-ketogenic DietExperimental Treatment2 Interventions
Participants with Bipolar Disorder will consume a ketogenic diet for the first phase of the study and then a non-ketogenic diet for the second phase of the study
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pittsburgh Medical CenterPittsburgh, PA
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Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
Baszucki Brain Research FundCollaborator
References
The use of the ketogenic diet in the treatment of psychiatric disorders. [2023]The ketogenic diet (KD) is a high-fat, low-carbohydrate, and moderate-protein diet that has shown benefit as a treatment in neurologic disorders and may serve as a therapeutic option in individuals with psychiatric disorders.
The ketogenic diet may have mood-stabilizing properties. [2008]The ketogenic diet, originally introduced in the 1920s, has been undergoing a recent resurgence as an adjunctive treatment for refractory epilepsy, particularly in children. In this difficult-to-treat population, the diet exhibits remarkable efficacy with two-thirds showing significant reduction in seizure frequency and one-third becoming nearly seizure-free. There are several reasons to suspect that the ketogenic diet may also have utility as a mood stabilizer in bipolar illness. These include the observation that several anticonvulsant interventions may improve outcome in mood disorders. Furthermore, beneficial changes in brain-energy profile are noted in subjects on the ketogenic diet. This is important since global cerebral hypometabolism is a characteristic of the brains of depressed or manic individuals. Finally, the extracellular changes that occur in ketosis would be expected to decrease intracellular sodium concentrations, a common property of all effective mood stabilizers. Trials of the ketogenic diet in relapse prevention of bipolar mood episodes are warranted.
Ketogenic diet experience at Ondokuz Mayıs University. [2021]The ketogenic diet (KD) is a special diet that is rich in fat, and poor in protein and carbohydrates. KD is the first-line treatment for some metabolic disorders, and is also used in resistant epilepsy, autism, cancer, Parkinson, Alzheimer's diseases, and stroke. The KD team consists of a doctor (child neurologist), nurse, and dietician. After diet adjustment, family training, metabolic tests, consultations, material supply, the initial and follow-up stages are performed by this team.
The ketogenic diet and other dietary treatments for refractory epilepsy in children. [2021]The ketogenic diet is a high-fat, low-carbohydrate, and restricted protein diet that is useful in patients with refractory epilepsy. The efficacy of the ketogenic diet is better than most of the new antiepileptic drugs. Other modifications of the diet are also beneficial, such as the modified Atkins diet and the low glycemic index treatment. There is a lack of awareness of the ketogenic diet as a treatment modality for epilepsy amongst pediatricians and neurologists. In this review, the use of the ketogenic diet and other dietary treatments in refractory epilepsy is discussed. The Indian experience with the use of these dietary treatments is also briefly reviewed.
Ketosis and bipolar disorder: controlled analytic study of online reports. [2023]Members of online bipolar disorder forums often report experiences of mood-stabilisation on the ketogenic diet, which has traditionally been used in the treatment of epilepsy. We examined the nature and extent of such reports.
Long-term health consequences of epilepsy diet treatments. [2022]The ketogenic diet (KD) typically provides a marginally healthy diet and in recent years has been used for more protracted courses of therapy. This results in concern about the impact of the diet on the general health of the child. Studies have demonstrated poor growth, dyslipidemia, kidney stones, and numerous other problems seen less frequently. Major areas of concern are reviewed as well as some emerging evidence of more beneficial long-term health consequences beyond the expected control of seizures.
The ketogenic diet for Dravet syndrome and other epileptic encephalopathies: an Italian consensus. [2017]Ketogenic diet is a nonpharmacologic treatment for childhood epilepsy not amenable to drugs. At the present time, two works based on national research, one in Germany and one in the United States provide international guidelines to ensure a correct management of the ketogenic diet. Our Italian collaborative study group was set up in order to formulate a consensus statement regarding the clinical management of the ketogenic diet, patient selection, pre-ketogenic diet, counseling, setting and enforcement of dietary induction of ketosis, follow-up management, and eventual discontinuation of the diet.
Efficacy and safety of the ketogenic diet for intractable childhood epilepsy: Korean multicentric experience. [2022]We wished to evaluate the efficacy and safety of the ketogenic diet (KD), and we also evaluated the prognosis of the patients after successful discontinuation of the diet in infants, children, and adolescents with refractory epilepsy.
Not your parents' ketogenic diet - Flexibility in 2020. [2021]This is a commentary on the details of the increasing flexibility of the original classic ketogenic diet, a well-known evidence-based treatment option for intractable epilepsy. The variety of ketogenic diet therapies (KDT) have shown similar efficacy to the classic version. Initiation protocols, outpatient diet starts, hospital teaching kitchens, premade ketogenic foods and ways to calculate and administer the diet are readily available for ketogenic professionals and their patients. This approach to a more flexible diet management may help to make KDTs easier in compliance, palatability and reducing the risk of side effects.
Self-reported medication adherence and its correlates in a lithium-maintained cohort with bipolar disorder at a tertiary care centre in India. [2020]Lithium remains a cornerstone of prophylaxis in bipolar disorder (BD), but adherence continues to be a major clinical challenge and merits a closer attention. There is scant literature available in Indian as well as Asian context.
[The Management of Common Bile Duct Stones]. [2018]Common bile duct (CBD) stone is a relatively frequent disorder with a prevalence of 10-20% in patients with gallstones. This is also associated with serious complications, including obstructive jaundice, acute suppurative cholangitis, and acute pancreatitis. Early diagnosis and prompt treatment is the most important for managing CBD stones. According to a recent meta-analysis, endoscopic ultrasonography and magnetic resonance cholangiopancreatography have high sensitivity, specificity, and accuracy for the diagnosis of CBD stones. Endoscopic ultrasonography, in particular, has been reported to have higher sensitivity between them. A suggested management algorithm for patients with symptomatic gallstones is based on whether they are at low, intermediate, or high probability of CBD stones. Single-stage laparoscopic CBD exploration and cholecystectomy is superior to endoscopic retrograde cholangiopancreatography (ERCP) plus laparoscopic cholecystectomy with respect to technical success and shorter hospital stay in high risk patients with gallstones and CBD stones, where expertise, operative time, and instruments are available. ERCP plus laparoscopic cholecystectomy is usually performed to treat patients with CBD stones and gallstones in many institutions. Patients at intermediate probability of CBD stones after initial evaluation benefit from additional biliary imaging. Patients with a low probability of CBD stones should undergo cholecystectomy without further evaluation. Endoscopic sphincterotomy and endoscopic papillary balloon dilation in ERCP are the primary methods for dilating the papilla of Vater for endoscopic removal of CBD stones. Endoscopic papillary large balloon dilation is now increasingly performed due to the usefulness in the management of giant or difficult CBD stones. Scheduled repeated ERCP may be considered in patients with high risk of recurrent CBD stones.
Suspected common bile duct stones: reduction of unnecessary ERCP by pre-procedural imaging and timing of ERCP. [2023]Endoscopic retrograde cholangiopancreatography (ERCP) is the procedure of choice to remove sludge/stones from the common bile duct (CBD). In a small but clinically important proportion of patients with suspected choledocholithiasis ERCP is negative. This is undesirable because of ERCP associated morbidity. We aimed to map the diagnostic pathway leading up to ERCP and evaluate ERCP outcome.
Laparoscopic management after failed endoscopic stone removal in nondilated common bile duct. [2022]When common bile duct (CBD) stone removal by endoscopic procedure fails, CBD exploration is an alternative procedure. However, nondilated CBD is a contraindication to choledochotomy. The purpose of this study was to investigate the results of laparoscopic CBD exploration (LCBDE) following unsuccessful endoscopic stone removal in nondilated CBD.
Long term outcomes of choledochoduodenostomy for common bile duct stones in the era of laparoscopy and endoscopy. [2015]Choledochoduodenostomy (CDD) has been reported as an effective treatment of Common bile duct stones (CBDS). This study was designed to analyze short term and long term outcomes of CDD for CBDS.