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NCT05968638 · ClinicalTrials.gov registry record · NA

Ketogenic Diet in People With Schizophrenia

A NA study of Schizophrenia and Schizo Affective Disorder, sponsored by University of Maryland, Baltimore.

Active
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT05968638 is a NA study of Schizophrenia and Schizo Affective Disorder that is active but no longer recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 50 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05968638, a NA study of Schizophrenia and Schizo Affective Disorder, is active but no longer recruiting, sponsored by University of Maryland, Baltimore.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

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

Interventions

  • OTHER Regular Diet
  • OTHER Ketogenic Diet

Study Locations (1)

Maryland

  • Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) - Catonsville

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-09-01
Est. Completion 2027-08-01
Phase NA

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT05968638

The ClinicalTrials.gov registry entry for NCT05968638 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (77% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Regular Diet is the first listed.

NCT05968638 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT05968638 about?

NCT05968638 is a clinical study titled "Ketogenic Diet in People With Schizophrenia". 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 ca...

What is the current status of trial NCT05968638?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2023-09-01. Estimated completion is 2027-08-01.

What conditions does trial NCT05968638 study?

This clinical trial studies the following conditions: Schizophrenia, Schizo Affective Disorder.

What interventions are being tested in trial NCT05968638?

The interventions under investigation include: Regular Diet (OTHER), Ketogenic Diet (OTHER).

Who is sponsoring clinical trial NCT05968638?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05968638 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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