Elucidating Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD): a Multidisciplinary Mechanistic Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
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⁃ All participants:

• 18-40 years of age

• Not following a ketogenic diet

⁃ BD hypomanic group (n=30):

• Meeting sex proportion: 50% female

• Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5)

• Score greater than 10 on the Young Mania Rating Scale score(YMRS)

• BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)

⁃ BD euthymic group (n=30):

• Meeting sex proportion: 50% female

• Meeting diagnosis proportion: 50:50% BDI:II (DSM-5)

• Score less than or equal to 10 on YMRS

• BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD)

⁃ Healthy Control (HC) Group (n=30):

• Sex matched with BD groups

• No psychiatric history

Locations
United States
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Contact Information
Primary
Jill Morris-Tillman
morristillmanje@upmc.edu
412-383-8206
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2027-01
Participants
Target number of participants: 107
Treatments
Experimental: 1st phase Non-ketogenic Diet / 2nd phase Ketogenic Diet
Participants with Bipolar Disorder will consume a non-ketogenic diet for the first phase of the study and then a ketogenic diet for the second phase of the study
Experimental: 1st phase Ketogenic Diet / 2nd phase Non-ketogenic Diet
Participants with Bipolar Disorder will consume a ketogenic diet for the first phase of the study and then a non-ketogenic diet for the second phase of the study
Other: No diet
Participants without Bipolar Disorder will not participate in the diet phases of the study
Related Therapeutic Areas
Sponsors
Collaborators: Baszucki Brain Research Fund
Leads: University of Pittsburgh

This content was sourced from clinicaltrials.gov