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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03010865
• Other study ID #: 2016-12
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: June 1, 2017
• Est. completion date: February 2020

Study information

• Verified date: June 2017
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Schizophrenia
• Schizophrenic Disorder

Intervention

Drug:
• Sodium Butyrate
Sodium butyrate is being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) in 730 mg capsules. The company asserts that their material is 98% pure and food grade. We will have identical placebo capsules. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 4380 mg/day.
• Placebo Oral Capsule
Placebo Oral Capsule is also being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) and there is no difference from appearance, smell and taste. It contains 1.5 mg sodium butyrate per capsule. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 9 mg/day.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Stanley Medical Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in Side-Effect Scale Score	Patient self-report of side-effects of active or placebo medication	Basline, week 2, week 6, up to 12 weeks
Primary	Change from baseline in MATRICS Battery Score	MATRICS Cognitive Battery	Basline, week 6, up to 12 weeks
Secondary	Change from baseline in Logical Memory Test score	Logical Memory Test for longer term memory	Basline, up to 12 weeks
Secondary	Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score	Positive and Negative Syndrome Scale (PANSS) symptom rating scale	Basline, week 6, up to 12 weeks
Secondary	Change from baseline in Paced Auditory Serial Addition Test (PASAT) score	Alternate working memory test	Basline, week 6, up to 12 weeks
Secondary	Change from baseline in UCSD Performance-Based Skills Assessment (UPSA) total score	University of California, San Diego (UCSD) Performance-Based Skills Assessment Battery	Baseline, up to 12 weeks