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Ketogenic Diet in People With Schizophrenia

StatusTerminated
PhaseNot applicable
Started
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Record History

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  1. Stopped Trial terminated Sponsor's reason: Secretary of Health for the State of MD halted all inpatient research that was not federally funded
    • Final enrollment: 4 participants — 8% of the 50 planned
    • Primary completion date changed from estimate of Aug 1, 2026 to Aug 1, 2025
    • Eligibility criteria expanded, about 28 words
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Aug 1, 2023 to Sep 1, 2023
    • Eligibility criteria expanded, about 12 words
    • Site details revised
    • Study title shortened, about 5 words
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Schizophrenia is a serious mental disorder with a heterogenous presentation, lack of clear understanding of pathophysiology and only partially effective treatments. First-line antipsychotic drugs block dopamine, but many people continue to suffer from persistent positive or negative symptoms that cannot be fully treated with available medications. Recently, our group has found that dietary modulations have efficacy comparable to antipsychotic medications and that determining which patients could benefit from a personalized treatment framework is critical. The ketogenic diet consists of low-carbohydrate, moderate protein and high fat intake inducing a state in which ketone bodies in the blood provide energy to the cells. In pharmacologic mouse models a ketogenic diet regimen resulted in complete restoration of normal behaviors, independent of strict caloric restriction and other work has suggested that a ketogenic diet may improve schizophrenia like deficits in rodents. An open label ketogenic diet study in the 1950s reported improvement in schizophrenia symptom. At least 7 additional case reports have found robust improvements or complete resolution of schizophrenia symptoms. Recently a retrospective study found robust and significant improvements in schizophrenia symptoms in 10 schizoaffective disorder patients treated with a ketogenic diet. In addition to psychiatric symptoms, improvements in metabolic outcomes have been demonstrated. However, to date, there have been no published double blind randomized controlled trials evaluating the effects of a ketogenic diet since few sites can conduct inpatient trials and have observation and control for food intake
Trial Details
NCT Number NCT05968638
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)
Schizophrenia, Schizo Affective Disorder
Related terms Psychotic Disorders, Schizophrenia
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov