Bipolar Disorder
Conditions
Keywords
ketogenic, long-acting injectable, rural
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTKetogenic foodstuffs
Weekly food box, selected from rotating menu of three options, as designed by study dietician to include ketogenic foodstuffs.
Oral mood stabilizing antipsychotics for the treatment of bipolar disorder. These medications may include second generation antipsychotic mood stabilizing medications aripiprazole, risperidone, quetiapine, and olanzapine.
OTHERStandard of care long acting injectable medication for bipolar disorder
Long-acting injectable antipsychotic mood stabilizing medication for bipolar disorder. The medication used may include aripiprazole monohydrate.
Sponsors
University of Alabama at Birmingham
Baszucki Family Foundation
Baptist Health System Montgomery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 * Verified Bipolar Diagnosis per NETSCID
Exclusion criteria
* Acute psychiatric instability (manic episode, active suicidality requiring hospitalization) * Anorexia * Pregnancy * Severe renal insufficiency * Hepatic insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact on Symptom Severity as measured by Young Mania Ratings Scale | T0 (time of intake); T0+1 week; T0+2 weeks; T0+3 weeks; T0+4 weeks; T0+6 weeks; T0+8 weeks; T0+10 weeks; T0+12 weeks; T0+16 weeks; T0+20 weeks; T0+24 weeks | The Young Mania Rating Scale (YMRS) is a clinical assessment tool specifically designed to evaluate manic symptoms and their severity. The YMRS comprises 11 items. Each item is rated on a scale that varies in range, typically from 0 to 4 or 0 to 8, allowing for a nuanced measurement of symptoms. The total score can range from 0 to 60, with higher scores indicating more severe manic symptoms. |
Countries
United States
Contacts
CONTACTWill Rutland, MD
PRINCIPAL_INVESTIGATORWill Rutland, MD
UAB Heersink School of Medicine - Montgomery Psychiatry
Outcome results
None listed