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| ID | Type | Description | Link |
|---|---|---|---|
| PF-2025-025 | Other Grant/Funding Number | Baszucki Family Foundation |
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| Name | Class |
|---|---|
| Baszucki Family Foundation | OTHER |
| Baptist Health System Montgomery | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral bipolar medication only | Active Comparator | 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. |
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| Long-acting injectable medication only | Active Comparator | Participants in this arm will receive long-acting injectable medication as treatment for bipolar disorder. This medication may include aripiprazole monohydrate. |
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| Oral medication + ketogenic diet | Experimental | 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. |
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| Long-acting injectable medication + ketogenic diet | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic foodstuffs | Dietary Supplement | Weekly food box, selected from rotating menu of three options, as designed by study dietician to include ketogenic foodstuffs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Impact on Symptom Severity as measured by Young Mania Ratings Scale | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Will Rutland, MD | Contact | 334-747-7550 | wrutland@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Will Rutland, MD | UAB Heersink School of Medicine - Montgomery Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center South | Montgomery | Alabama | 36116-2496 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37595997 | Background | Yildiz A, Siafis S, Mavridis D, Vieta E, Leucht S. Comparative efficacy and tolerability of pharmacological interventions for acute bipolar depression in adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2023 Sep;10(9):693-705. doi: 10.1016/S2215-0366(23)00199-2. | |
| 38547601 | Background |
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| Standard of Care Oral antipsychotics | Other | 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. |
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| Standard of care long acting injectable medication for bipolar disorder | Other | Long-acting injectable antipsychotic mood stabilizing medication for bipolar disorder. The medication used may include aripiprazole monohydrate. |
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| Sethi S, Wakeham D, Ketter T, Hooshmand F, Bjornstad J, Richards B, Westman E, Krauss RM, Saslow L. Ketogenic Diet Intervention on Metabolic and Psychiatric Health in Bipolar and Schizophrenia: A Pilot Trial. Psychiatry Res. 2024 May;335:115866. doi: 10.1016/j.psychres.2024.115866. Epub 2024 Mar 20. |
| 34642461 | Background | Kishi T, Ikuta T, Matsuda Y, Sakuma K, Okuya M, Nomura I, Hatano M, Iwata N. Pharmacological treatment for bipolar mania: a systematic review and network meta-analysis of double-blind randomized controlled trials. Mol Psychiatry. 2022 Feb;27(2):1136-1144. doi: 10.1038/s41380-021-01334-4. Epub 2021 Oct 12. |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C101544 | MD1 |
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