Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep O… (NCT06748950) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling
United States120 participantsStarted 2025-07
Plain-language summary
The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. diagnosed with bipolar disorder (BD), major depressive disorder (MDD), and or schizophrenia
✓. For individuals diagnosed with bipolar disorder (BD):
✓. For individuals diagnosed with major depressive disorder (MDD):
✓. For individuals diagnosed with schizophrenia:
✓. Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy or other psychiatric medication. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least four weeks prior to screening and if it is expected to remain stable. Participants may be switched from other classes of medication to another medication class by their psychiatrist or primary care doctor, but need to be stable enough to enroll and adhere to study procedures.
✓. willing and able to give informed consent for participation in English.
✓. live within the United States.
Exclusion criteria
✕. has started the ketogenic diet or was in ketosis within 3 months of wanting to enroll
✕. pregnant or nursing
✕. insulin dependent
✕. comorbidity of developmental delay
✕. in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary programs.
What they're measuring
1
WHO-5 Well-being Index
Timeframe: Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).
2
Functioning Assessment Short Test (FAST)
Timeframe: Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).
3
Quality of Life Scale (QIDS)
Timeframe: Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover).