Sodium Butyrate For Improving Cognitive Function In Schizophrenia

Withdrawn before enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Schizophrenic Disorders, Cognitive Function

In brief

The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment for cognitive deficits in schizophrenia (SZ). The proposal consists of a small preliminary open label study to assess tolerability and side effects of sodium butyrate in schizophrenic patients receiving antipsychotic treatment, followed by a larger double-blind study of the effects of sodium butyrate on cognitive function and symptoms in SZ patients who are not in an acute exacerbation of the primary symptoms and show continued cognitive deficits. Secondary 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.

Key facts

Study ID

NCT02654405

Run by

Nathan Kline Institute for Psychiatric Research

People needed

0

Starts

2016-04-01

Expected to finish

2016-05-01

Last updated by the study team

2016-08-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis by DSM-5 (Diagnostic Statistical Manual) diagnosis of SZ or schizoaffective disorder (SA), by consensus diagnosis using chart histories and interviews.
• Age 18-60 years of age.
• Patients will be stably treated with antipsychotic medications and are not in acute illness exacerbation of their symptoms.
• For the double-blind phase only qualification for cognitive deficits will use the following criteria:
• Subjects will have baseline MCCB battery scores which meet the following criteria. Subjects will meet the following cognitive performance criteria: a). Maximum performance level: Performance at least 1.0 standard deviation (SD) from perfect on the following three measures: Letter-number span (< 24), Hopkins Verbal Learning Test (HVLT) total (<31), Continuous Performance Test (CPT) d-prime (< 3.47) and b.
• Minimum performance level: subject must be able to validly complete the baseline MATRICS assessment.

You may not qualify if…

• History of mental retardation or pervasive developmental disorder.
• Subjects with a current serious neurological/central nervous system (CNS) disorder (such as seizure disorder, stroke or multiple sclerosis) or brain trauma.
• Current treatment with valproic acid, butyrate drugs, sulforaphane, or other drugs or chemicals known to have high HDAC inhibitory activity.
• Pregnancy.
• Severe unstable current medical condition.
• Current suicidal or homicidal thoughts.
• Current alcohol or substance abuse (other than nicotine or occasional marijuana) in the last month.
• Subjects with diagnosis of congestive heart failure, or those on sodium restricted diet.

Where it is running

• Nathan Kline Insitute for Psychiatric Research — Orangeburg, New York, United States

Full record on ClinicalTrials.gov

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