Sodium Butyrate For Improving Cognitive Function In Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03010865|
Recruitment Status : Withdrawn (sponsor withdrew the funds because the smell of sodium butyrate made blinding impossible)
First Posted : January 5, 2017
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenic Disorder Cognitive Impairment||Drug: Sodium Butyrate Drug: Placebo Oral Capsule||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sodium Butyrate As A Treatment For Improving Cognitive Function In Schizophrenia|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||February 2020|
Experimental: Sodium Butyrate
Dietary Supplement: Sodium Butyrate 4.38 gms of sodium butyrate per day for 12 weeks
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 Comparator: Placebo Oral Capsule
Placebo Oral Capsule placebo capsules containing approximately 9 mg of sodium butyrate per day
Drug: 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.
- Change from baseline in MATRICS Battery Score [ Time Frame: Basline, week 6, up to 12 weeks ]MATRICS Cognitive Battery
- Change from baseline in Logical Memory Test score [ Time Frame: Basline, up to 12 weeks ]Logical Memory Test for longer term memory
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Basline, week 6, up to 12 weeks ]Positive and Negative Syndrome Scale (PANSS) symptom rating scale
- Change from baseline in Paced Auditory Serial Addition Test (PASAT) score [ Time Frame: Basline, week 6, up to 12 weeks ]Alternate working memory test
- Change from baseline in UCSD Performance-Based Skills Assessment (UPSA) total score [ Time Frame: Baseline, up to 12 weeks ]University of California, San Diego (UCSD) Performance-Based Skills Assessment Battery
- Change from baseline in Side-Effect Scale Score [ Time Frame: Basline, week 2, week 6, up to 12 weeks ]Patient self-report of side-effects of active or placebo medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010865
|Shanghai Mental Health Center|
|Shanghai, Shanghai, China, 200030|
|Principal Investigator:||Chunbo Li, M.D.||Shanghai Mental Health Center|