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Sodium Butyrate For Improving Cognitive Function In Schizophrenia

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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Recruitment Status : Withdrawn (sponsor withdrew the funds because the smell of sodium butyrate made blinding impossible)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
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenic Disorder Cognitive Impairment Drug: Sodium Butyrate Drug: Placebo Oral Capsule Phase 2 Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change from baseline in MATRICS Battery Score [ Time Frame: Basline, week 6, up to 12 weeks ]
    MATRICS Cognitive Battery


Secondary Outcome Measures :
  1. Change from baseline in Logical Memory Test score [ Time Frame: Basline, up to 12 weeks ]
    Logical Memory Test for longer term memory

  2. 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

  3. Change from baseline in Paced Auditory Serial Addition Test (PASAT) score [ Time Frame: Basline, week 6, up to 12 weeks ]
    Alternate working memory test

  4. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Mental Health Center
Stanley Medical Research Institute
Investigators
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Principal Investigator: Chunbo Li, M.D. Shanghai Mental Health Center
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03010865    
Other Study ID Numbers: 2016-12
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Stanley foundation requests: Based on the terms of your award, Stanley Medical Research Institute (SMRI) now requires submission of the individual patient data from all SMRI funded studies. In order to make the process as efficient as possible and provide a secure location for study data, National Institute of Mental Health (NIMH) is graciously allowing SMRI access to their National Database for Clinical Trials (NDCT) to collect and house data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Mental Health Center:
HDAC inhibitors
Inflammation
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Butyric Acid
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs