Sodium Butyrate For Improving Cognitive Function In Schizophrenia

• Status: Withdrawn
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Collaborator: Stanley Medical Research Institute
• Treatments: Butyric Acid

Criteria

Inclusion Criteria:

1. Subjects who have cognitive deficits as indicated by a score of < 85 on RBANS,

2. meet criteria for DSM-5 diagnosis of chronic SZ, schizoaffective disorder (SA),

3. Subjects who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms.

Exclusion Criteria:

1. History of mental retardation or pervasive developmental disorder,

2. Subjects with a current serious neurological/CNS disorder (such as seizure disorder, stroke or multiple sclerosis) or brain trauma,

3. Current treatment with valproic acid, butyrate drugs, sulforaphane, or other drugs or chemicals known to have high HDAC inhibitory activity,

4. Pregnancy,

5. Severe unstable medical condition,

6. Current suicidal or homicidal thoughts,

7. Current alcohol or substance abuse (other than nicotine or occasional marijuana) in the last month.