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

NCT07570875 | Not Yet Recruiting

• 2 other identifiers: IRB-300016223PF-2025-025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

ketogenic; long-acting injectable; rural

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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.

Other: Standard of Care Oral antipsychotics

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.

Other: Standard of care long acting injectable medication for bipolar disorder

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.

Dietary Supplement: Ketogenic foodstuffs; Other: Standard of Care Oral antipsychotics

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.

Dietary Supplement: Ketogenic foodstuffs; Other: Standard of care long acting injectable medication for bipolar disorder

Interventions

Ketogenic foodstuffs DIETARY_SUPPLEMENT

Weekly food box, selected from rotating menu of three options, as designed by study dietician to include ketogenic foodstuffs.

Long-acting injectable medication + ketogenic diet; Oral medication + ketogenic diet

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.

Oral bipolar medication only; Oral medication + ketogenic diet

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.

Long-acting injectable medication + ketogenic diet; Long-acting injectable medication only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Verified Bipolar Diagnosis per NETSCID

You may not qualify if:

• Acute psychiatric instability (manic episode, active suicidality requiring hospitalization)
• Anorexia
• Pregnancy
• Severe renal insufficiency
• Hepatic insufficiency

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Baptist Health System Montgomery: collaborator
• Baszucki Family Foundation: collaborator

Study Sites (1)

Baptist Medical Center South

Montgomery, Alabama, 36116-2496, United States

Location

Related Publications (3)

• Yildiz, A., Siafis, S., Mavridis, D., Vieta, E., & Leucht, S. (2023). Comparative efficacy and tolerability of pharmacological interventions for acute bipolar depression in adults: a systematic review and network meta-analysis. The lancet. Psychiatry, 10(9), 693-705. https://doi.org/10.1016/S2215-0366(23)00199-2

  BACKGROUND

• Sethi, S., Wakeham, D., Ketter, T., Hooshmand, F., Bjornstad, J., Richards, B., Westman, E., Krauss, R. M., & Saslow, L. (2024). Ketogenic Diet Intervention on Metabolic and Psychiatric Health in Bipolar and Schizophrenia: A Pilot Trial. Psychiatry research, 335, 115866. https://doi.org/10.1016/j.psychres.2024.115866

  BACKGROUND

• Kishi, T., Ikuta, T., Matsuda, Y., Sakuma, K., Okuya, M., Nomura, I., Hatano, M., & Iwata, N. (2022). Pharmacological treatment for bipolar mania: a systematic review and network meta-analysis of double-blind randomized controlled trials. Molecular psychiatry, 27(2), 1136-1144. https://doi.org/10.1038/s41380-021-01334-4

  BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

MD1

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Will Rutland, MD

  UAB Heersink School of Medicine - Montgomery Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Will Rutland, MD

CONTACT

334-747-7550; wrutland@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regional Chair of Psychiatry - Montgomery Campus

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)