Overseen ByDeanna L Kelly, Pharm.D., BCPP
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Maryland, Baltimore
Trial Summary
What is the purpose of this trial?This trial is testing if a special high-fat, low-carb diet can help people with schizophrenia who don't get better with regular medications. The diet changes how the body gets energy, which might improve brain function and reduce symptoms. The ketogenic diet has shown benefits in epilepsy and other neurological conditions, suggesting it may also help with psychiatric conditions.
Eligibility Criteria
Adults aged 18-64 with schizophrenia or schizoaffective disorder, stable on antipsychotics for at least two weeks, and a BMI over 18.5 can join this trial. They must score sufficiently on tests to show they understand the consent process. Excluded are pregnant women, those with severe heart, kidney or liver issues, certain metabolic disorders, eating disorders or alcohol use disorder.Inclusion Criteria
Minimum score of 45 on BPRS
I have been diagnosed with schizophrenia or schizoaffective disorder.
My antipsychotic medication dose has been stable for the last 14 days.
+3 more
Exclusion Criteria
Refusal to eat intervention diet, food allergies or restrictions that the kitchen cannot accommodate, and/or dietary noncompliance with dietary energy needs
Corrected QT interval (QTc) prolongation greater than or equal to 500ms
I have a serious kidney condition.
+10 more
Participant Groups
This study is testing whether a ketogenic diet (high fat, low carb) helps improve symptoms of schizophrenia compared to a regular diet. It's designed as a double-blind controlled trial but hasn't been done before due to challenges in monitoring food intake in patients.
2Treatment groups
Active Control
Placebo Group
Group I: Ketogenic DietActive Control1 Intervention
Group II: Regular DietPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)Catonsville, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor