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Sodium Butyrate For Improving Cognitive Function In Schizophrenia

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ClinicalTrials.gov Identifier: NCT02654405
Recruitment Status : Withdrawn (Nathan Kline Institute (NKI) decided not to accept study grant from Stanley Medical Research Foundation. because of budget considerations.)
First Posted : January 13, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research

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 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.


Condition or disease Intervention/treatment Phase
Schizophrenic Disorders Cognitive Function Dietary Supplement: Sodium Butyrate Other: Placebo Phase 2 Phase 3

  Show Detailed Description

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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
Study Start Date : April 2016
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Sodium Butyrate
6.57 gms of sodium butyrate per day for 12 weeks
Dietary Supplement: Sodium Butyrate
6.57 gms of sodium butyrate per day for 12 weeks

Placebo Comparator: Placebo
Placebo capsule with 2 mg of sodium butyrate for making taste or odor, (9 mg/day)
Other: Placebo
placebo capsules containing approximately 9 mg of sodium butyrate/day




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


Secondary Outcome Measures :
  1. Change from baseline Logical Memory test score [ Time Frame: baseline, 12 weeks ]
    Logical Memory Test for longer Term Memory

  2. Change from baseline in PANSS Total Score [ Time Frame: baseline, 6 weeks, up to 12 weeks ]
    PANSS symptom rating scale

  3. Change from baseline in PASAT Score [ Time Frame: baseline,6 weeks, up to 12 weeks ]
    Alternate working memory test

  4. change from baseline in UPSA Total score [ Time Frame: baseline, 12 weeks ]
    USCD (University of California San Diego) Performance- Based Skills Assessment Battery


Other Outcome Measures:
  1. Change from baseline in Side-Effect Scale Score [ Time Frame: baseline,2 weeks, 6 weeks, up to 12 weeks ]
    Patient self-report of side-effects of active or placebo medication

  2. Change from baseline in clinical laboratory measures [ Time Frame: baseline, 12 weeks ]
    common clinical laboratory parameters



Information from the National Library of Medicine

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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. Diagnosis by DSM-5 (Diagnostic Statistical Manual) diagnosis of SZ or schizoaffective disorder (SA), by consensus diagnosis using chart histories and interviews.
  2. Age 18-60 years of age.
  3. 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:

  4. 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.
  5. Minimum performance level: subject must be able to validly complete the baseline MATRICS assessment.

Exclusion Criteria:

  1. History of mental retardation or pervasive developmental disorder.
  2. Subjects with a current serious neurological/central nervous system (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 current medical condition.
  6. Current suicidal or homicidal thoughts.
  7. Current alcohol or substance abuse (other than nicotine or occasional marijuana) in the last month.
  8. Subjects with diagnosis of congestive heart failure, or those on sodium restricted diet.

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): NCT02654405


Locations
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United States, New York
Nathan Kline Insitute for Psychiatric Research
Orangeburg,, New York, United States, 10962
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Stanley Medical Research Institute
Investigators
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Principal Investigator: Robert C Smith, M.D., Ph.D Nathan Kline Institute for Pstychiatric Research

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Responsible Party: Robert C. Smith MD PhD, Research Psychiatrist, Research Professor of Psychiatry, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT02654405     History of Changes
Other Study ID Numbers: 809383
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
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
Keywords provided by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:
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