Ketogenic Therapy for Bipolar Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a ketogenic diet, high in fat and low in carbs, can help manage bipolar disorder symptoms when combined with standard medications. The researchers focus on how this diet might make treatment more accessible and affordable for people in rural areas around Montgomery, Alabama. Participants will either continue with their regular medication or add the ketogenic diet to their treatment plan to determine which approach is more effective. This trial may suit individuals with confirmed bipolar disorder who are currently stable and not experiencing a severe episode. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance treatment accessibility and effectiveness for bipolar disorder.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. It seems like the ketogenic diet is meant to be added to your existing treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research suggests that a ketogenic diet might be safe and helpful for people with bipolar disorder. This high-fat, low-carb diet could stabilize mood and improve symptoms. A small study found that it might also enhance brain function, offering promise for those with severe mental health issues.
Although researchers have not yet conducted large studies, early findings indicate that people generally tolerate the ketogenic diet well. Some research has shown positive effects on mood and mental health without major side effects. However, as with any dietary change, individuals may experience different reactions and need time to adjust.
Overall, current evidence suggests that the ketogenic diet is generally safe for people with bipolar disorder when used alongside their regular treatments.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ketogenic therapy for bipolar disorder because it introduces a unique approach that combines traditional medication with a specialized high-fat, low-carb diet. This diet, known as the ketogenic diet, is thought to alter brain energy metabolism, potentially leading to mood stabilization. While standard treatments primarily focus on chemical balance through medications like antipsychotics, the ketogenic diet offers a novel mechanism by influencing brain function through nutrition. This innovative approach could offer a complementary way to manage bipolar disorder, potentially enhancing the effectiveness of existing medications.
What evidence suggests that this trial's treatments could be effective for bipolar disorder?
Research suggests that a ketogenic diet might help treat bipolar disorder. Some reports and studies have shown that people on this diet experienced more stable moods and improved thinking skills. A small clinical trial found that a ketogenic diet might help balance the brain's energy use, which can affect mental health. Another study found that higher levels of ketones (produced when the body breaks down fat) were linked to better mood and energy. In this trial, certain participants will receive a ketogenic diet alongside their medication regimen. While more research is needed, these early findings suggest that a ketogenic diet could serve as a helpful additional treatment for bipolar disorder.12567
Who Is on the Research Team?
Will Rutland, MD
Principal Investigator
UAB Heersink School of Medicine - Montgomery Psychiatry
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a confirmed diagnosis of bipolar disorder. People cannot join if they are currently in a manic episode, have active suicidal thoughts needing hospitalization, have anorexia, are pregnant, or have severe kidney or liver problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either oral or long-acting injectable medication, with or without a ketogenic diet, for bipolar disorder
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ketogenic Therapy
Trial Overview
The study tests whether adding a high-fat/low-carb ketogenic diet to standard bipolar treatments (injectable and oral medications) can help reduce symptoms and side effects for people living with bipolar disorder in rural Alabama.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants in this arm will receive oral medication for bipolar disorder, plus foodstuffs necessary to support ketogenic diet. Oral medications may include second generation antipsychotic mood stabilizing medications aripiprazole, risperidone, quetiapine, and olanzapine.
Participants in this arm will receive long-acting injectable medication for bipolar disorder, plus foodstuffs necessary to support ketogenic diet. The medication used may include aripiprazole monohydrate.
Participants in this arm will receive oral medication treatment as usual for bipolar disorder. These medications may include second generation antipsychotic mood stabilizing medications aripiprazole, risperidone, quetiapine, and olanzapine.
Participants in this arm will receive long-acting injectable medication as treatment for bipolar disorder. This medication may include aripiprazole monohydrate.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Baszucki Family Foundation
Collaborator
Baptist Health System Montgomery
Collaborator
Citations
Pilot study of a ketogenic diet in bipolar disorder - PMC - NIH
Recent evidence from case reports suggests that a ketogenic diet may be effective for bipolar disorder. However, no clinical trials have been conducted to date.
Retrospective case study: ketogenic metabolic therapy in ...
The narrative highlighted a marked improvement in mood stability, cognitive function, and overall well-being, endorsing the effectiveness of KMT ...
Pilot study shows ketogenic diet improves severe mental illness
A small clinical trial led by Stanford Medicine found that the metabolic effects of a ketogenic diet may help stabilize the brain.
Ketogenic diet as a metabolic therapy for bipolar disorder
This review highlights underlying metabolic mechanisms of BD and potential therapeutic effects of a low carbohydrate ketogenic diet (KD) on mood symptoms.
Evaluating the Impact of Ketogenic Therapy on Symptom ...
It is the purpose of this pilot study to evaluate a high-fat/low-carbohydrate "ketogenic" diet-based intervention as an adjunctive strategy for ...
Child Bipolar Network Ketogenic Diet Approach to ...
The investigators hypothesize that youth who complied with the 16-week keto diet therapy will show statistically significant reductions in bipolar mood ...
The effects of ketogenic metabolic therapy on mental ...
More recent data from open clinical trials have pointed toward a dramatic reduction in psychotic, affective, and metabolic symptoms in both ...
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