Sodium Butyrate For Improving Cognitive Function In Schizophrenia

Cognitive Impairment Clinical Trial

Official title: Sodium Butyrate As A Treatment For Improving Cognitive Function In Schizophrenia

Status Withdrawn

Clinical Trial Summary

The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment for cognitive deficits in schizophrenia (SZ). The aims will be to evaluate its effects on improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects to epigenetic and inflammation related biochemical changes.

Clinical Trial Description

The persistent cognitive deficits which can be appreciated across the course of SZ, from prodromal to chronic SZ, may be the most important underlying dysfunction in preventing functional, occupational, and social recovery in SZ compared to other symptom domains. Sodium butyrate is a short chain fatty acid and binds to the zinc site of histone deacetylases (HDAC). The inhibition of HDAC results in histone hyperacetylation. This study aims to evaluate its effects on improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects to epigenetic and inflammation related biochemical changes.

The proposed study will be a double blind study of the effects of sodium butyrate on cognitive function and symptoms in chronic SZ patients showing continued cognitive deficits.The primary specific aims of the proposal will be to test the the MATRICS (MCCB) battery,delayed recall performance, and performance on real world functional tasks as assessed by the USCD Performance- Based Skills Assessment Battery (UPSA). In addition, we will also investigate whether sodium butyrate may improve other aspects of cognition.

We will also explore whether improvement in cognition is related to change in HDAC activity in peripheral blood cells and changes in inflammatory makers in the blood, and assess whether there is any improvement in psychopathology as measured by PANSS scale. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Schizophrenia
• Schizophrenic Disorder

• NCT number: NCT03010865
• Study type: Interventional
• Source: Shanghai Mental Health Center
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: June 1, 2017
• Completion date: February 2020