Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area
Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area - A Four-Arm Pilot Study
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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Will Rutland, MD
- 전화번호: 334-747-7550
- 이메일: wrutland@uab.edu
연구 장소
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Alabama
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Montgomery, Alabama, 미국, 36116-2496
- Baptist Medical Center South
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연락하다:
- Will Rutland, MD
- 전화번호: 3347477550
- 이메일: wrutland@uab.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Oral bipolar medication only
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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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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활성 비교기: Long-acting injectable medication only
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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Long-acting injectable antipsychotic mood stabilizing medication for bipolar disorder.
The medication used may include aripiprazole monohydrate.
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실험적: Oral medication + ketogenic diet
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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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.
Weekly food box, selected from rotating menu of three options, as designed by study dietician to include ketogenic foodstuffs.
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실험적: Long-acting injectable medication + ketogenic diet
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.
|
Long-acting injectable antipsychotic mood stabilizing medication for bipolar disorder.
The medication used may include aripiprazole monohydrate.
Weekly food box, selected from rotating menu of three options, as designed by study dietician to include ketogenic foodstuffs.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Impact on Symptom Severity as measured by Young Mania Ratings Scale
기간: 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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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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공동 작업자 및 조사자
수사관
- 수석 연구원: Will Rutland, MD, UAB Heersink School of Medicine - Montgomery Psychiatry
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-300016223
- PF-2025-025 (기타 보조금/기금 번호: Baszucki Family Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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