Ketogenic Intervention for Bipolar Depression

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07121894
Status
Recruiting
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Conditions

  • Bipolar Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketogenic Diet — BEHAVIORAL
    Participants will initiate a modified ketogenic diet under structured, intensive guidance. Simultaneously, participants will attend weekly behavioral support interviews with a psychiatrist to monitor mental health and mood stability.

Study Details

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.

Key Dates

Start date
Aug 12, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
May 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ketogenic Diet
    Patients diagnosed with bipolar disorder and experiencing depression or depressive symptoms.

Primary Outcome Measure

Change in depressive symptoms [ Time Frame: Baseline, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Karin Lindstrom, PhD
[email protected]
507-293-3876
Kyla M Lara-Breitinger, MD (PRINCIPAL_INVESTIGATOR)
Mark Frye, MD (PRINCIPAL_INVESTIGATOR)

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