Ketogenic Therapy for Bipolar Disorder

Overseen By Will Rutland, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Acute psychiatric instability, Anorexia, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

It is the purpose of this pilot study to evaluate a high-fat/low-carbohydrate "ketogenic" diet-based intervention as an adjunctive strategy for impacting symptoms of bipolar disorder. The study is designed to evaluate this impact in the rural southern catchment area around Montgomery, Alabama.

While existing access and cost barriers can prevent effective treatment of bipolar disorder in the rural south, using food as medicine represents a possible alternative/adjunctive to traditional high-cost/low-access medications. Specifically, this study will evaluate the impact of combining a ketogenic diet with existing treatment options, under the conditions of the rural catchment area, to determine the impact and efficacy of this intervention at patient and systems levels.

If effective, the interventions examined in this pilot study may increase the efficacy, availability and access to care experienced by individuals living with bipolarity in the rural Deep South.

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?

Inclusion Criteria

I am over 18 years old.

Verified Bipolar Diagnosis per NETSCID

Exclusion Criteria

Acute psychiatric instability (manic episode, active suicidality requiring hospitalization)

I have a loss of appetite.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral or long-acting injectable medication, with or without a ketogenic diet, for bipolar disorder

24 weeks

11 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic Therapy

How Is the Trial Designed?

Group I: Oral medication + ketogenic diet Experimental Treatment 2 Interventions

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.

Group II: Long-acting injectable medication + ketogenic diet Experimental Treatment 2 Interventions

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.

Group III: Oral bipolar medication only Active Control 1 Intervention

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.

Group IV: Long-acting injectable medication only Active Control 1 Intervention

Participants in this arm will receive long-acting injectable medication as treatment for bipolar disorder. This medication may include aripiprazole monohydrate.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Baszucki Family Foundation

Collaborator

Baptist Health System Montgomery

Collaborator