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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketogenic foodstuffs, Standard of Care Oral antipsychotics, Standard of care long acting injectable medication for bipolar disorder.
- Who it may be relevant to
- Registry conditions: Bipolar Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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 supplement Ketogenic foodstuffs
Weekly food box, selected from rotating menu of three options, as designed by study dietician to include ketogenic foodstuffs. - Other Standard of Care Oral antipsychotics
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. - Other Standard 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.
Primary outcome measures
- Impact on Symptom Severity as measured by Young Mania Ratings Scale [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Baptist Medical Center South — Montgomery
Publications
- 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. PMID 37595997
- 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. PMID 38547601
- 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. PMID 34642461
Identifiers
NCT: NCT07570875 · IRB-300016223 · PF-2025-025