Bipolar Depression / Ketogenic Diet · Interventional Study

Ketogenic Intervention for Bipolar Depression

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a recruiting single-arm interventional study registered to evaluate ketogenic diet in bipolar depression, with primary outcome change in depressive symptoms at 6 months. No results are posted in this registry record, and the study remains open to recruitment.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Bipolar Depression; age from 18 Years; to 50 Years. Intervention: Ketogenic Diet. n = 30. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a recruiting interventional study with no posted results; it represents early-phase work designed to assess feasibility and correlates rather than establish efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in depressive symptoms (assessed at Baseline, 6 months)

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationBipolar Depression; age from 18 Years; to 50 Years

Sample size30

InterventionKetogenic Diet

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment30

Primary outcome measureChange in depressive symptoms, Baseline, 6 months

Caveats

No results are reported in this registry record; study status is recruiting.
No comparator arm is specified; single-arm design limits causal inference.
Study phase is listed as 'NA'; no Phase designation given.
No effect sizes, p-values, or outcome data available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm behavioral intervention; no control group specified in registry.

Directness

moderate

Primary outcome is depressive symptoms change; clinically relevant but no hard endpoints reported.

Consistency

insufficient

No results posted; cannot assess internal or external consistency.

Risk of bias

insufficient

Registry record only; no conduct or blinding details provided to assess bias.

Sample adequacy

limited

Estimated enrollment 30 participants; small sample for definitive bipolar depression study.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07121894). This is a study registration, not published results. Lead sponsor: Mayo Clinic. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Bipolar Depression. Interventions: BEHAVIORAL: Ketogenic Diet. Primary outcome measures: Change in depressive symptoms , Baseline, 6 months. Brief summary: The purpose of this study is to assess the clinical correlates of therapeutic precision ketosis in bipolar depression and to evaluate the cardiometabolic correlates associated with therapeutic precision ketosis in bipolar depression.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Bipolar DepressionNCT07121894Mayo ClinicKetogenic Diet