A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
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• Between the ages of 18 and 45.
• Ability to adhere to study diets.
• Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years.
• Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening
• Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study.
Locations
United States
Massachusetts
McLean Hospital
RECRUITING
Belmont
Contact Information
Primary
Jacey Anderson, B.A.
janderson75@mclean.harvard.edu
617-855-3988
Backup
Virginie-Anne Chouinard, MD
vchouinard@mclean.harvard.edu
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 50
Treatments
Active_comparator: Ketogenic diet arm
Eligible participants assigned to the ketogenic diet arm will be asked to follow the ketogenic diet (KD) for 12 weeks in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive weekly and as needed diet counseling from a registered dietician. Participants will be asked to monitor and report their blood ketone levels each day via a finger-prick device provided by the study team. Participants have the ability to opt into an optional open label phase where they can continue on the ketogenic diet with the daily finger pricks for another 12 weeks after the 12-week main study.
Active_comparator: Dietary Guidelines for Americans arm
Eligible participants assigned to the Dietary Guidelines for Americans (DGA) arm will adhere to the Dietary Guidelines for Americans in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive weekly and as needed diet counseling from a registered dietician. Participants will be asked to monitor and report their blood ketone levels each day via a finger-prick device provided by the study team. Participants have the ability to opt into an optional open label phase where they can switch to the ketogenic diet with the daily finger pricks for 12 weeks after the 12-week main study.
Related Therapeutic Areas
Sponsors
Collaborators: Baszucki Family Foundation
Leads: Mclean Hospital